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Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles

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ClinicalTrials.gov Identifier: NCT03312543
Recruitment Status : Completed
First Posted : October 17, 2017
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Skin Aging
Interventions Device: Active Mask
Device: Sham Mask
Enrollment 124
Recruitment Details  
Pre-assignment Details At Visit 1 (Screening), participants were enrolled in the study and randomized to the active cell or the sham cell (stratified by skin type). All participants received the same facial cleanser and moisturizer with SPF to use between Visit 1 and Visit 2, and then received the assigned test product (Active Mask or Sham Mask) at Visit 2 (Baseline).
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Period Title: Before Treatment (Screening to Baseline)
Started 61 63
Completed 60 59
Not Completed 1 4
Reason Not Completed
Lost to Follow-up             0             2
Withdrawal by Subject             1             2
Period Title: Treatment (Baseline to Week 12)
Started 60 59
Completed 56 54
Not Completed 4 5
Reason Not Completed
Withdrawal by Subject             3             4
Protocol Violation             1             1
Period Title: Regression (Week 12 to Week 24)
Started 56 54
Completed 55 52
Not Completed 1 2
Reason Not Completed
Protocol Violation             1             1
Death             0             1
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask Total
Hide Arm/Group Description A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. Total of all reporting groups
Overall Number of Baseline Participants 61 63 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 63 participants 124 participants
56.3  (8.02) 56.6  (7.34) 56.5  (7.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
Female
61
 100.0%
63
 100.0%
124
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
Hispanic or Latino
1
   1.6%
1
   1.6%
2
   1.6%
Not Hispanic or Latino
60
  98.4%
62
  98.4%
122
  98.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  24.6%
18
  28.6%
33
  26.6%
White
45
  73.8%
45
  71.4%
90
  72.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.6%
0
   0.0%
1
   0.8%
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
I
11
  18.0%
11
  17.5%
22
  17.7%
II
11
  18.0%
11
  17.5%
22
  17.7%
III
9
  14.8%
11
  17.5%
20
  16.1%
IV
10
  16.4%
11
  17.5%
21
  16.9%
V
10
  16.4%
9
  14.3%
19
  15.3%
VI
10
  16.4%
10
  15.9%
20
  16.1%
[1]
Measure Description: Measure of skin type characteristics including sensitivity to burning/tanning. Ranges from I to VI, where I = white, very fair; red or blond hair; blue eyes; freckles; always burns easily, never tans. VI = Black; black hair, black eyes. Never burns, deeply pigmented.
Skin Oiliness Level   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
Oily
2
   3.3%
4
   6.3%
6
   4.8%
Dry
9
  14.8%
13
  20.6%
22
  17.7%
Normal
23
  37.7%
17
  27.0%
40
  32.3%
Combination
27
  44.3%
29
  46.0%
56
  45.2%
[1]
Measure Description: Self-perceived facial skin type in terms of oiliness level with answer choices of oily, dry, normal, or combination skin.
1.Primary Outcome
Title Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores
Hide Description 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.18  (0.328) 0.30  (0.341)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Cell: Sham Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
0.09 to 0.26
Parameter Dispersion
Type: Standard Deviation
Value: 0.328
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Cell: Active Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.21 to 0.39
Parameter Dispersion
Type: Standard Deviation
Value: 0.341
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Cell: Sham Mask, Active Cell: Active Mask
Comments [Not Specified]
Type of Statistical Test Other
Comments The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method ANCOVA
Comments With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
0.02 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.060
Estimation Comments [Not Specified]
2.Primary Outcome
Title Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1
Hide Description Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 1 were calculated individually.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a scale.
0.20  (0.349) 0.22  (0.328)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Cell: Sham Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
0.11 to 0.29
Parameter Dispersion
Type: Standard Deviation
Value: 0.349
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Cell: Active Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
0.13 to 0.31
Parameter Dispersion
Type: Standard Deviation
Value: 0.328
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Cell: Sham Mask, Active Cell: Active Mask
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.
Statistical Test of Hypothesis P-Value 0.540
Comments [Not Specified]
Method ANCOVA
Comments With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.09 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.062
Estimation Comments [Not Specified]
3.Primary Outcome
Title Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2
Hide Description Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 2 were calculated individually.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a scale.
-0.03  (0.532) 0.21  (0.500)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Cell: Sham Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis P-Value 0.627
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.17 to 0.10
Parameter Dispersion
Type: Standard Deviation
Value: 0.532
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Cell: Active Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.08 to 0.34
Parameter Dispersion
Type: Standard Deviation
Value: 0.500
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Cell: Sham Mask, Active Cell: Active Mask
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANCOVA
Comments With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.06 to 0.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.092
Estimation Comments [Not Specified]
4.Primary Outcome
Title Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3
Hide Description Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 3 were calculated individually.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a scale.
0.36  (0.465) 0.47  (0.578)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Cell: Sham Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.23 to 0.48
Parameter Dispersion
Type: Standard Deviation
Value: 0.465
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Cell: Active Mask
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.32 to 0.63
Parameter Dispersion
Type: Standard Deviation
Value: 0.578
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Cell: Sham Mask, Active Cell: Active Mask
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.
Statistical Test of Hypothesis P-Value 0.224
Comments [Not Specified]
Method ANCOVA
Comments With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.07 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.094
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Global Wrinkling - Change From Baseline to Week 1
Hide Description 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.03  (0.158) 0.04  (0.157)
6.Secondary Outcome
Title Global Wrinkling - Change From Baseline to Week 4
Hide Description 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.09  (0.208) 0.09  (0.198)
7.Secondary Outcome
Title Global Wrinkling - Change From Baseline to Week 24
Hide Description 3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.24  (0.410) 0.30  (0.378)
8.Secondary Outcome
Title Fine Lines - Change From Baseline to Week 1
Hide Description 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.01  (0.132) 0.05  (0.160)
9.Secondary Outcome
Title Fine Lines - Change From Baseline to Week 4
Hide Description 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.08  (0.196) 0.13  (0.205)
10.Secondary Outcome
Title Fine Lines - Change From Baseline to Week 12
Hide Description 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.23  (0.309) 0.32  (0.358)
11.Secondary Outcome
Title Fine Lines - Change From Baseline to Week 24
Hide Description 3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.28  (0.358) 0.29  (0.349)
12.Secondary Outcome
Title Periorbital Wrinkles - Change From Baseline to Week 1
Hide Description 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.00  (0.176) 0.01  (0.172)
13.Secondary Outcome
Title Periorbital Wrinkles - Change From Baseline to Week 4
Hide Description 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.10  (0.269) 0.10  (0.246)
14.Secondary Outcome
Title Periorbital Wrinkles - Change From Baseline to Week 12
Hide Description 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 64
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.15  (0.355) 0.30  (0.366)
15.Secondary Outcome
Title Periorbital Wrinkles - Change From Baseline to Week 24
Hide Description 3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.22  (0.399) 0.29  (0.401)
16.Secondary Outcome
Title Surface Roughness - Change From Baseline to Week 1
Hide Description 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.35  (0.396) 0.38  (0.386)
17.Secondary Outcome
Title Surface Roughness - Change From Baseline to Week 4
Hide Description 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.79  (0.438) 0.76  (0.520)
18.Secondary Outcome
Title Surface Roughness - Change From Baseline to Week 12
Hide Description 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.94  (0.449) 0.89  (0.576)
19.Secondary Outcome
Title Surface Roughness - Change From Baseline to Week 24
Hide Description 3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
1.12  (0.549) 0.95  (0.686)
20.Secondary Outcome
Title Uneven Skin Tone - Change From Baseline to Week 1
Hide Description 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.04  (0.176) 0.06  (0.119)
21.Secondary Outcome
Title Uneven Skin Tone - Change From Baseline to Week 4
Hide Description 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.18  (0.282) 0.23  (0.287)
22.Secondary Outcome
Title Uneven Skin Tone - Change From Baseline to Week 12
Hide Description 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.36  (0.388) 0.49  (0.487)
23.Secondary Outcome
Title Uneven Skin Tone - Change From Baseline to Week 24
Hide Description 3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.44  (0.378) 0.52  (0.499)
24.Secondary Outcome
Title Mottled Hyperpigmentation - Change From Baseline to Week 1
Hide Description 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.01  (0.166) -0.02  (0.174)
25.Secondary Outcome
Title Mottled Hyperpigmentation - Change From Baseline to Week 4
Hide Description 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.10  (0.313) 0.15  (0.288)
26.Secondary Outcome
Title Mottled Hyperpigmentation - Change From Baseline to Week 12
Hide Description 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.22  (0.456) 0.39  (0.392)
27.Secondary Outcome
Title Mottled Hyperpigmentation - Change From Baseline to Week 24
Hide Description 3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.25  (0.467) 0.31  (0.401)
28.Secondary Outcome
Title Sallowness/Yellowing - Change From Baseline to Week 1
Hide Description 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.01  (0.276) 0.01  (0.179)
29.Secondary Outcome
Title Sallowness/Yellowing - Change From Baseline to Week 4
Hide Description 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.12  (0.247) 0.12  (0.354)
30.Secondary Outcome
Title Sallowness/Yellowing - Change From Baseline to Week 12
Hide Description 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.23  (0.390) 0.33  (0.496)
31.Secondary Outcome
Title Sallowness/Yellowing - Change From Baseline to Week 24
Hide Description 3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.29  (0.445) 0.32  (0.504)
32.Secondary Outcome
Title Lack of Radiance - Change From Baseline to Week 1
Hide Description 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 59 57
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.07  (0.219) 0.13  (0.258)
33.Secondary Outcome
Title Lack of Radiance - Change From Baseline to Week 4
Hide Description 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.28  (0.357) 0.37  (0.401)
34.Secondary Outcome
Title Lack of Radiance - Change From Baseline to Week 12
Hide Description 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.41  (0.412) 0.55  (0.493)
35.Secondary Outcome
Title Lack of Radiance - Change From Baseline to Week 24
Hide Description 3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description:
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.54  (0.454) 0.59  (0.517)
Time Frame Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 24 unless terminated early). Serious adverse events (SAE) reported to the site were also reportable within 30 days of last procedure/visit and longer if considered study-related; there was no specific cut-off date for this reporting, but AEs/SAEs are shown in this posting for a collection period of approximately 6 months from last subject's visit (the time of this posting).
Adverse Event Reporting Description The Investigator or a designee interviewed subjects for changes in health/medication at each visit, documenting any reported adverse events. The analysis population is all randomized subjects who used the investigational device (i.e. the subjects enrolled in the treatment period).
 
Arm/Group Title Sham Cell: Sham Mask Active Cell: Active Mask
Hide Arm/Group Description A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued. A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
All-Cause Mortality
Sham Cell: Sham Mask Active Cell: Active Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)      1/59 (1.69%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sham Cell: Sham Mask Active Cell: Active Mask
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      1/59 (1.69%)    
General disorders     
Sudden Death  1 [1]  0/60 (0.00%)  0 1/59 (1.69%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
[1]
Subject died during the regression period. Event was classified as "not study-related."
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sham Cell: Sham Mask Active Cell: Active Mask
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/60 (6.67%)      5/59 (8.47%)    
Infections and infestations     
Upper Respiratory Tract Infection  1  1/60 (1.67%)  1 5/59 (8.47%)  5
Oral Herpes  1  3/60 (5.00%)  3 0/59 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI must provide Sponsor 60 days to review any publication (unless expedited review requested); if it includes Sponsor's confidential info, written Sponsor approval is required. Sponsor may require another 60 days' delay to file a patent application.
Results Point of Contact
Name/Title: Sidney Hornby
Organization: Johnson & Johnson Consumer Inc.
Phone: 908-874-2756
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
ClinicalTrials.gov Identifier: NCT03312543     History of Changes
Other Study ID Numbers: CO-170511132943-SACT
First Submitted: October 6, 2017
First Posted: October 17, 2017
Results First Submitted: January 4, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019