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A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne. (TIGER)

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ClinicalTrials.gov Identifier: NCT02698436
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Device: Acne Mask
Drug: 2.5% Benzoyl Peroxide Treatment
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acne Mask Benzoyl Peroxide 2.5%
Hide Arm/Group Description Light therapy mask applied to the face once in the evening for a duration of 10 minutes Apply test product to face once in the morning and once at night.
Period Title: Overall Study
Started 59 58
Completed 52 51
Not Completed 7 7
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             3             3
Lost to Follow-up             2             4
Non-compliance with study regimen             1             0
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide Treatment Total
Hide Arm/Group Description Light therapy mask applied to the face once in the evening for a duration of 10 minutes Applied BPO treatment once daily Total of all reporting groups
Overall Number of Baseline Participants 59 58 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 58 participants 117 participants
17.8  (5.79) 18.7  (5.97) 18.2  (5.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
Female
31
  52.5%
31
  53.4%
62
  53.0%
Male
28
  47.5%
27
  46.6%
55
  47.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 59 participants 58 participants 117 participants
59 58 117
1.Primary Outcome
Title Percent Change of Global Face Total Acne Lesion Count From Baseline
Hide Description [Not Specified]
Time Frame Baseline to 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 55 54
Mean (95% Confidence Interval)
Unit of Measure: Percent change of acne lesion count
-44
(-51 to -37)
-54
(-61 to -45)
2.Secondary Outcome
Title Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1
Hide Description [Not Specified]
Time Frame Baseline to 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 54 54
Mean (95% Confidence Interval)
Unit of Measure: Percent change of acne lesion count
-19
(-25 to -13)
-26
(-33 to -19)
3.Secondary Outcome
Title Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2
Hide Description [Not Specified]
Time Frame Baseline to 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 52 52
Mean (95% Confidence Interval)
Unit of Measure: Percent change of acne lesion count
-28
(-35 to -21)
-42
(-48 to -35)
4.Secondary Outcome
Title Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4
Hide Description [Not Specified]
Time Frame Baseline to 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 54 52
Mean (95% Confidence Interval)
Unit of Measure: Percent change of acne lesion count
-35
(-42 to -27)
-46
(-53 to -39)
5.Secondary Outcome
Title Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8
Hide Description [Not Specified]
Time Frame Baseline to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 52 51
Mean (95% Confidence Interval)
Unit of Measure: Percent change of acne lesion count
-40
(-46 to -33)
-50
(-62 to -38)
6.Secondary Outcome
Title Acne Lesion Counts Total Global Face - Baseline
Hide Description Acne Lesion Count Total Global Face at Baseline
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 55 54
Mean (Standard Deviation)
Unit of Measure: Lesion Count
47.2  (22.56) 47.6  (23.22)
7.Secondary Outcome
Title Acne Lesion Counts Total Global Face - Week 1
Hide Description Acne Lesion Count Total Global Face Week 1
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 54 54
Mean (Standard Deviation)
Unit of Measure: Lesion Count
39.2  (22.5) 36.8  (24.00)
8.Secondary Outcome
Title Acne Lesion Counts Total Global Face - Week 2
Hide Description Acne Lesion Count Total Global Face Week 2
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: Lesion Count
35.3  (20.13) 30.5  (22.88)
9.Secondary Outcome
Title Acne Lesion Counts Total Global Face - Week 4
Hide Description Acne Lesion Count Total Global Face Week 4
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 54 52
Mean (Standard Deviation)
Unit of Measure: Lesion Count
30.5  (17.51) 27.0  (19.76)
10.Secondary Outcome
Title Acne Lesion Counts Total Global Face - Week 8
Hide Description Acne Lesion Count Total Global Face Week 8
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 52 51
Mean (Standard Deviation)
Unit of Measure: Lesion Count
27.8  (16.06) 26.4  (28.40)
11.Secondary Outcome
Title Acne Lesion Counts Total Global Face - Week 12
Hide Description Acne Lesion Count Total Global Face Week 12
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 52 51
Mean (Standard Deviation)
Unit of Measure: Lesion Count
24.8  (15.76) 23.3  (20.91)
12.Secondary Outcome
Title Investigator Global Acne Assessment - Baseline
Hide Description

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

  1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
  2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
  3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
  4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
  5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 55 54
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.55  (0.529) 2.51  (0.471)
13.Secondary Outcome
Title Investigator Global Acne Assessment - Week 1
Hide Description

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

  1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
  2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
  3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
  4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
  5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 54 54
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.35  (0.538) 2.34  (0.548)
14.Secondary Outcome
Title Investigator Global Acne Assessment - Week 2
Hide Description

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

  1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
  2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
  3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
  4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
  5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.23  (0.598) 2.11  (0.605)
15.Secondary Outcome
Title Investigator Global Acne Assessment - Week 4
Hide Description

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

  1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
  2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
  3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
  4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
  5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 54 52
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.08  (0.612) 1.87  (0.650)
16.Secondary Outcome
Title Investigator Global Acne Assessment - Week 8
Hide Description

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

  1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
  2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
  3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
  4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
  5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 52 51
Mean (Standard Deviation)
Unit of Measure: Score on a scale
1.88  (0.583) 1.70  (0.775)
17.Secondary Outcome
Title Investigator Global Acne Assessment - Week 12
Hide Description

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

  1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
  2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
  3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
  4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
  5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide
Hide Arm/Group Description:
Light therapy mask applied to the face once in the evening for a duration of 10 minutes
Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Overall Number of Participants Analyzed 52 51
Mean (Standard Deviation)
Unit of Measure: Score on a scale
1.77  (0.660) 1.59  (0.726)
Time Frame Adverse events were collected from the time the informed consent/assent was obtained through the subject's last study procedure/visit. Serious adverse events were also collected 30 calendar days beyond the subject's last procedure/visit and longer if study-related.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acne Mask 2.5% Benzoyl Peroxide Treatment
Hide Arm/Group Description Light therapy mask applied to the face once in the evening for a duration of 10 minutes Applied BPO treatment once daily
All-Cause Mortality
Acne Mask 2.5% Benzoyl Peroxide Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/58 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acne Mask 2.5% Benzoyl Peroxide Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/58 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acne Mask 2.5% Benzoyl Peroxide Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/58 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Lisa Fitzgerald
Organization: JNJWorldwide
Phone: +1 908-904-6235
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT02698436     History of Changes
Other Study ID Numbers: CO-151211140520-SACT
First Submitted: February 26, 2016
First Posted: March 3, 2016
Results First Submitted: August 29, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018