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Trial record 5 of 233 for:    acne AND Percent

A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03124381
Recruitment Status : Completed
First Posted : April 21, 2017
Results First Posted : November 9, 2018
Last Update Posted : February 15, 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: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Device: Cleanser, Acne Mask
Device: Cleanser, Gel-Cream, Acne Mask
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description Cleanser, Gel-Cream, Acne Mask Cleanser, Acne Mask
Period Title: Overall Study
Started 65 61
Completed 56 55
Not Completed 9 6
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             6             3
Protocol Violation             0             1
Adverse Event             1             1
Non-Compliance with Study Treatment             1             0
Arm/Group Title Gel-Cream + Acne Mask Acne Mask Total
Hide Arm/Group Description Cleanser, Gel-Cream, Acne Mask Cleanser, Acne Mask Total of all reporting groups
Overall Number of Baseline Participants 65 61 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 61 participants 126 participants
18.8  (6.03) 20.0  (7.65) 19.4  (6.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Female
38
  58.5%
32
  52.5%
70
  55.6%
Male
27
  41.5%
29
  47.5%
56
  44.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Hispanic or Latino
25
  38.5%
23
  37.7%
48
  38.1%
Not Hispanic or Latino
40
  61.5%
38
  62.3%
78
  61.9%
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 65 participants 61 participants 126 participants
American Indian or Alaska Native
1
   1.5%
1
   1.6%
2
   1.6%
Asian
3
   4.6%
1
   1.6%
4
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  18.5%
10
  16.4%
22
  17.5%
White
47
  72.3%
47
  77.0%
94
  74.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   3.1%
2
   3.3%
4
   3.2%
Skin Sensitivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
None of the Time
38
  58.5%
40
  65.6%
78
  61.9%
Some of the Time
21
  32.3%
18
  29.5%
39
  31.0%
Most of the Time
6
   9.2%
1
   1.6%
7
   5.6%
All of the Time
0
   0.0%
2
   3.3%
2
   1.6%
[1]
Measure Description: Self-perceived skin sensitivity. Do you consider your skin to be sensitive...none of the time, some of the time, most of the time, all of the time
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
I
0
   0.0%
0
   0.0%
0
   0.0%
II
24
  36.9%
28
  45.9%
52
  41.3%
III
18
  27.7%
14
  23.0%
32
  25.4%
IV
12
  18.5%
10
  16.4%
22
  17.5%
V
10
  15.4%
6
   9.8%
16
  12.7%
VI
1
   1.5%
3
   4.9%
4
   3.2%
[1]
Measure Description: Description:Measure of skin type characteristics, including sensitivity to burning/tanning. Ranging from I to VI, where I = White; very fair; red or blonde hair; blue eyes; freckles; Always burns easily; never tans and VI = Black; black hair, black eyes, black skin; Never burns; deeply pigmented
1.Primary Outcome
Title Global Face Total Lesion Count - Percent Change - Baseline to Week 12
Hide Description Percent change from baseline in global face total lesion count at Week 12
Time Frame Baseline and 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. There was no post-baseline data to carry forward for three subjects.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Percent Change in Lesions
-42.64  (31.817) -47.80  (30.209)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gel-Cream + Acne Mask, Acne Mask
Comments Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority concluded if the upper bound of the two-sided 95% confidence interval (based on ANCOVA) is less than 15 percentage points. Terms for treatment, gender, center as factors and baseline as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.19
Confidence Interval (2-Sided) 95%
-7.04 to 13.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.164
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gel-Cream + Acne Mask, Acne Mask
Comments Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A−B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.
Type of Statistical Test Superiority
Comments Superiority concluded if the upper bound of the two-sided 95% confidence interval of the treatment difference is less than 0. Terms for treatment, gender, and center as factors and baseline score as covariate.
Statistical Test of Hypothesis P-Value 0.538
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.19
Confidence Interval (2-Sided) 95%
-7.04 to 13.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.164
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Global Face Total Lesion Count - Percent Change - Baseline to Week 2
Hide Description Percent change from baseline in global face total lesion count at Week 2
Time Frame Baseline and Week 2
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Percent Change in Lesions
-24.16  (25.646) -27.97  (21.330)
3.Secondary Outcome
Title Global Face Total Lesion Count - Percent Change - Baseline to Week 4
Hide Description Percent change from baseline in global face total lesion count at Week 4
Time Frame Baseline and 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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Percent Change in Lesions
-29.78  (27.388) -38.25  (22.729)
4.Secondary Outcome
Title Global Face Total Lesion Count - Percent Change - Baseline to Week 8
Hide Description Percent change from baseline in global face total lesion count at Week 8
Time Frame Baseline and Week 8
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Percent Change in Lesions
-39.81  (26.192) -45.86  (23.369)
5.Secondary Outcome
Title Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits
Hide Description Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated.
Time Frame Baseline to Week 2, Week 4, Week 8, and 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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Percent Change in Lesions
-33.68  (24.212) -39.79  (20.754)
6.Secondary Outcome
Title Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4
Hide Description Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated.
Time Frame Baseline to Week 2 and 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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Percent Change in Lesions
-26.95  (24.419) -33.01  (19.648)
7.Secondary Outcome
Title Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8
Hide Description Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated.
Time Frame Baseline to Week 4 and Week 8
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Percent Change in Lesions
-34.34  (25.438) -42.09  (21.082)
8.Secondary Outcome
Title Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12
Hide Description Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated.
Time Frame Baseline to Week 8 and 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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 58 55
Mean (Standard Deviation)
Unit of Measure: Percent Change in Lesions
-41.73  (27.472) -47.25  (46.201)
9.Secondary Outcome
Title Global Face Open Comedones Count - Week 2
Hide Description Open comedones count on global face - Week 2
Time Frame 2 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Open Comedones
8.1  (10.68) 5.6  (6.41)
10.Secondary Outcome
Title Global Face Open Comedones Count - Week 4
Hide Description Open comedones count on global face - Week 4
Time Frame 4 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Open Comedones
7.9  (10.37) 5.3  (6.27)
11.Secondary Outcome
Title Global Face Open Comedones Count - Week 8
Hide Description Open comedones count on global face - Week 8
Time Frame 8 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Open Comedones
5.1  (7.83) 4.5  (6.03)
12.Secondary Outcome
Title Global Face Open Comedones Count - Week 12
Hide Description Open comedones count on global face - Week 12
Time Frame 12 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Open Comedones
3.6  (5.2) 3.7  (6.31)
13.Secondary Outcome
Title Global Face Closed Comedones Count - Week 2
Hide Description Closed comedones count on global face - Week 2
Time Frame 2 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Closed Comedones
14.7  (10.66) 12.7  (9.41)
14.Secondary Outcome
Title Global Face Closed Comedones Count - Week 4
Hide Description Closed comedones count on global face - Week 4
Time Frame 4 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Closed Comedones
14.1  (11.69) 10.9  (7.01)
15.Secondary Outcome
Title Global Face Closed Comedones Count - Week 8
Hide Description Closed comedones count on global face - Week 8
Time Frame 8 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Closed Comedones
12.7  (10.38) 10.3  (7.05)
16.Secondary Outcome
Title Global Face Closed Comedones Count - Week 12
Hide Description Closed comedones count on global face - Week 12
Time Frame 12 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Closed Comedones
11.9  (10.01) 10.2  (9.00)
17.Secondary Outcome
Title Global Face Inflammatory Lesion Count - Week 2
Hide Description Papules and pustules counted together
Time Frame 2 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Inflammatory Lesions
12.1  (8.23) 10.3  (5.24)
18.Secondary Outcome
Title Global Face Inflammatory Lesion Count - Week 4
Hide Description Papules and pustules counted together
Time Frame 4 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Inflammatory Lesions
10.8  (7.56) 9.1  (6.15)
19.Secondary Outcome
Title Global Face Inflammatory Lesion Count - Week 8
Hide Description Papules and pustules counted together
Time Frame 8 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Inflammatory Lesions
9.9  (6.85) 7.8  (5.07)
20.Secondary Outcome
Title Global Face Inflammatory Lesion Count - Week 12
Hide Description Papules and pustules counted together
Time Frame 12 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Inflammatory Lesions
9.7  (7.19) 7.7  (6.44)
21.Secondary Outcome
Title Global Face Non-Inflammatory Lesion Count - Week 2
Hide Description Sum of open comedones and closed comedones
Time Frame 2 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Non-inflammatory Lesions
22.7  (15.94) 18.3  (11.74)
22.Secondary Outcome
Title Global Face Non-Inflammatory Lesion Count - Week 4
Hide Description Sum of open comedones and closed comedones
Time Frame 4 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Non-inflammatory lesions
22.0  (16.39) 16.2  (10.51)
23.Secondary Outcome
Title Global Face Non-Inflammatory Lesion Count - Week 8
Hide Description Sum of open comedones and closed comedones
Time Frame 8 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Non-inflammatory Lesions
17.8  (13.92) 14.8  (10.68)
24.Secondary Outcome
Title Global Face Non-Inflammatory Lesion Count - Week 12
Hide Description Sum of open comedones and closed comedones
Time Frame 12 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Non-inflammatory Lesions
15.6  (12.92) 14.0  (13.39)
25.Secondary Outcome
Title Global Face Total Lesion Count - Week 2
Hide Description Sum of inflammatory and non-inflammatory lesions
Time Frame 2 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Lesions
34.8  (19.30) 28.6  (13.10)
26.Secondary Outcome
Title Global Face Total Lesion Count - Week 4
Hide Description Sum of inflammatory and non-inflammatory lesions
Time Frame 4 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Lesions
32.8  (20.10) 25.2  (13.53)
27.Secondary Outcome
Title Global Face Total Lesion Count - Week 8
Hide Description Sum of inflammatory and non-inflammatory lesions
Time Frame 8 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Lesions
27.7  (17.41) 22.5  (13.95)
28.Secondary Outcome
Title Global Face Total Lesion Count - Week 12
Hide Description Sum of inflammatory and non-inflammatory lesions
Time Frame 12 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Lesions
25.3  (17.56) 21.7  (17.58)
29.Secondary Outcome
Title Investigator Global Acne Assessment - Week 1
Hide Description Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 64 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.29  (0.444) 2.27  (0.427)
30.Secondary Outcome
Title Investigator Global Acne Assessment - Week 2
Hide Description Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time Frame 2 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.17  (0.500) 2.06  (0.470)
31.Secondary Outcome
Title Investigator Global Acne Assessment - Week 4
Hide Description Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time Frame 4 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.00  (0.587) 1.90  (0.583)
32.Secondary Outcome
Title Investigator Global Acne Assessment - Week 8
Hide Description Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time Frame 8 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.84  (0.669) 1.73  (0.600)
33.Secondary Outcome
Title Investigator Global Acne Assessment - Week 12
Hide Description Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time Frame 12 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.64  (0.724) 1.64  (0.589)
34.Secondary Outcome
Title Overall Redness of Inflammatory Lesions - Week 1
Hide Description Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 64 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.88  (1.222) 5.05  (1.278)
35.Secondary Outcome
Title Overall Redness of Inflammatory Lesions - Week 2
Hide Description Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time Frame 2 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.65  (1.183) 4.74  (1.202)
36.Secondary Outcome
Title Overall Redness of Inflammatory Lesions - Week 4
Hide Description Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time Frame 4 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.49  (1.291) 4.41  (1.318)
37.Secondary Outcome
Title Overall Redness of Inflammatory Lesions - Week 8
Hide Description Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time Frame 8 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.30  (1.278) 4.25  (1.446)
38.Secondary Outcome
Title Overall Redness of Inflammatory Lesions - Week 12
Hide Description Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time Frame 12 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.96  (1.346) 3.97  (1.282)
39.Secondary Outcome
Title Overall Size of Inflammatory Lesions - Week 1
Hide Description Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 64 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.58  (1.298) 4.83  (1.371)
40.Secondary Outcome
Title Overall Size of Inflammatory Lesions - Week 2
Hide Description Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time Frame 2 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.17  (1.129) 4.56  (1.222)
41.Secondary Outcome
Title Overall Size of Inflammatory Lesions - Week 4
Hide Description Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time Frame 4 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.07  (1.273) 4.15  (1.408)
42.Secondary Outcome
Title Overall Size of Inflammatory Lesions - Week 8
Hide Description Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.
Time Frame 8 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.88  (1.290) 3.85  (1.606)
43.Secondary Outcome
Title Overall Size of Inflammatory Lesions - Week 12
Hide Description Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time Frame 12 weeks
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description:
Cleanser, Gel-Cream, Acne Mask
Cleanser, Acne Mask
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.67  (1.305) 3.59  (1.411)
Time Frame Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 12 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 1 year 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.
 
Arm/Group Title Gel-Cream + Acne Mask Acne Mask
Hide Arm/Group Description Cleanser, Gel-Cream, Acne Mask Cleanser, Acne Mask
All-Cause Mortality
Gel-Cream + Acne Mask Acne Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/61 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Gel-Cream + Acne Mask Acne Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gel-Cream + Acne Mask Acne Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/61 (0.00%) 
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 includes Sponsor’s confidential info, written Sponsor approval is required. Sponsor may require another 60 days’ delay to file patent app. If multicenter, PI agrees 1st publication is joint publication. If joint publication not submitted within 24 months of study end or Sponsor confirms there will be no joint publication, PI may publish the results individually following previous guidelines.
Results Point of Contact
Name/Title: Ali Fassih, Ph.D.
Organization: Johnson & Johnson Consumer Inc.
Phone: 908-904-3259
Publications:
Bashkatov, AN, et al. Optical properties of melanin in the skin and skin-like phantoms. Proc. of SPIE, 4162: 219-226, 2000.
Bashkatov, AN, et al. Optical properties of human skin, subcutaneous and mucous tissues in the wavelength range from 400 to 2000 nm. J Phys D: Appl Phys, 38: 2543-2555, 2005.
Wiegand, B, Luedtke, K, Rapp, SR. Acne Profile. Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933-7003, assignee. Patent US 2006/0008484 A1. 12 Jan. 2006. Print.
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
ClinicalTrials.gov Identifier: NCT03124381     History of Changes
Other Study ID Numbers: PS-170103145529-SACT
First Submitted: April 3, 2017
First Posted: April 21, 2017
Results First Submitted: September 4, 2018
Results First Posted: November 9, 2018
Last Update Posted: February 15, 2019