Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne (NCT NCT03124381)
NCT ID: NCT03124381
Last Updated: 2019-02-15
Results Overview
Percent change from baseline in global face total lesion count at Week 12
COMPLETED
NA
126 participants
Baseline and Week 12
2019-02-15
Participant Flow
Participant milestones
| Measure |
Gel-Cream + Acne Mask
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
61
|
|
Overall Study
COMPLETED
|
56
|
55
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Gel-Cream + Acne Mask
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Non-Compliance with Study Treatment
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne
Baseline characteristics by cohort
| Measure |
Gel-Cream + Acne Mask
n=65 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=61 Participants
Cleanser, Acne Mask
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.8 Years
STANDARD_DEVIATION 6.03 • n=5 Participants
|
20.0 Years
STANDARD_DEVIATION 7.65 • n=7 Participants
|
19.4 Years
STANDARD_DEVIATION 6.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Skin Sensitivity
None of the Time
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Skin Sensitivity
Some of the Time
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Skin Sensitivity
Most of the Time
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Skin Sensitivity
All of the Time
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
II
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
III
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
IV
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
V
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
VI
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
Percent change from baseline in global face total lesion count at Week 12
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Percent Change - Baseline to Week 12
|
-42.64 Percent Change in Lesions
Standard Deviation 31.817
|
-47.80 Percent Change in Lesions
Standard Deviation 30.209
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: 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.
Percent change from baseline in global face total lesion count at Week 2
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Percent Change - Baseline to Week 2
|
-24.16 Percent Change in Lesions
Standard Deviation 25.646
|
-27.97 Percent Change in Lesions
Standard Deviation 21.330
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: 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.
Percent change from baseline in global face total lesion count at Week 4
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Percent Change - Baseline to Week 4
|
-29.78 Percent Change in Lesions
Standard Deviation 27.388
|
-38.25 Percent Change in Lesions
Standard Deviation 22.729
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Percent change from baseline in global face total lesion count at Week 8
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Percent Change - Baseline to Week 8
|
-39.81 Percent Change in Lesions
Standard Deviation 26.192
|
-45.86 Percent Change in Lesions
Standard Deviation 23.369
|
SECONDARY outcome
Timeframe: Baseline to Week 2, Week 4, Week 8, and Week 12Population: 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.
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.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits
|
-33.68 Percent Change in Lesions
Standard Deviation 24.212
|
-39.79 Percent Change in Lesions
Standard Deviation 20.754
|
SECONDARY outcome
Timeframe: Baseline to Week 2 and Week 4Population: 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.
Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4
|
-26.95 Percent Change in Lesions
Standard Deviation 24.419
|
-33.01 Percent Change in Lesions
Standard Deviation 19.648
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and Week 8Population: 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
Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8
|
-34.34 Percent Change in Lesions
Standard Deviation 25.438
|
-42.09 Percent Change in Lesions
Standard Deviation 21.082
|
SECONDARY outcome
Timeframe: Baseline to Week 8 and Week 12Population: 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.
Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=58 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12
|
-41.73 Percent Change in Lesions
Standard Deviation 27.472
|
-47.25 Percent Change in Lesions
Standard Deviation 46.201
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Open comedones count on global face - Week 2
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Open Comedones Count - Week 2
|
8.1 Open Comedones
Standard Deviation 10.68
|
5.6 Open Comedones
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
Open comedones count on global face - Week 4
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Open Comedones Count - Week 4
|
7.9 Open Comedones
Standard Deviation 10.37
|
5.3 Open Comedones
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Open comedones count on global face - Week 8
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Open Comedones Count - Week 8
|
5.1 Open Comedones
Standard Deviation 7.83
|
4.5 Open Comedones
Standard Deviation 6.03
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Open comedones count on global face - Week 12
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=56 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Open Comedones Count - Week 12
|
3.6 Open Comedones
Standard Deviation 5.2
|
3.7 Open Comedones
Standard Deviation 6.31
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Closed comedones count on global face - Week 2
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Closed Comedones Count - Week 2
|
14.7 Closed Comedones
Standard Deviation 10.66
|
12.7 Closed Comedones
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
Closed comedones count on global face - Week 4
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Closed Comedones Count - Week 4
|
14.1 Closed Comedones
Standard Deviation 11.69
|
10.9 Closed Comedones
Standard Deviation 7.01
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Closed comedones count on global face - Week 8
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Closed Comedones Count - Week 8
|
12.7 Closed Comedones
Standard Deviation 10.38
|
10.3 Closed Comedones
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Closed comedones count on global face - Week 12
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=56 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Closed Comedones Count - Week 12
|
11.9 Closed Comedones
Standard Deviation 10.01
|
10.2 Closed Comedones
Standard Deviation 9.00
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Papules and pustules counted together
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Inflammatory Lesion Count - Week 2
|
12.1 Inflammatory Lesions
Standard Deviation 8.23
|
10.3 Inflammatory Lesions
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
Papules and pustules counted together
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Inflammatory Lesion Count - Week 4
|
10.8 Inflammatory Lesions
Standard Deviation 7.56
|
9.1 Inflammatory Lesions
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Papules and pustules counted together
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Inflammatory Lesion Count - Week 8
|
9.9 Inflammatory Lesions
Standard Deviation 6.85
|
7.8 Inflammatory Lesions
Standard Deviation 5.07
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Papules and pustules counted together
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=56 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Inflammatory Lesion Count - Week 12
|
9.7 Inflammatory Lesions
Standard Deviation 7.19
|
7.7 Inflammatory Lesions
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Sum of open comedones and closed comedones
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Non-Inflammatory Lesion Count - Week 2
|
22.7 Non-inflammatory Lesions
Standard Deviation 15.94
|
18.3 Non-inflammatory Lesions
Standard Deviation 11.74
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
Sum of open comedones and closed comedones
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Non-Inflammatory Lesion Count - Week 4
|
22.0 Non-inflammatory lesions
Standard Deviation 16.39
|
16.2 Non-inflammatory lesions
Standard Deviation 10.51
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Sum of open comedones and closed comedones
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Non-Inflammatory Lesion Count - Week 8
|
17.8 Non-inflammatory Lesions
Standard Deviation 13.92
|
14.8 Non-inflammatory Lesions
Standard Deviation 10.68
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Sum of open comedones and closed comedones
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=56 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Non-Inflammatory Lesion Count - Week 12
|
15.6 Non-inflammatory Lesions
Standard Deviation 12.92
|
14.0 Non-inflammatory Lesions
Standard Deviation 13.39
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Sum of inflammatory and non-inflammatory lesions
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Week 2
|
34.8 Lesions
Standard Deviation 19.30
|
28.6 Lesions
Standard Deviation 13.10
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
Sum of inflammatory and non-inflammatory lesions
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Week 4
|
32.8 Lesions
Standard Deviation 20.10
|
25.2 Lesions
Standard Deviation 13.53
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Sum of inflammatory and non-inflammatory lesions
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Week 8
|
27.7 Lesions
Standard Deviation 17.41
|
22.5 Lesions
Standard Deviation 13.95
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Sum of inflammatory and non-inflammatory lesions
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=56 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Global Face Total Lesion Count - Week 12
|
25.3 Lesions
Standard Deviation 17.56
|
21.7 Lesions
Standard Deviation 17.58
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=64 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Investigator Global Acne Assessment - Week 1
|
2.29 Units on a scale
Standard Deviation 0.444
|
2.27 Units on a scale
Standard Deviation 0.427
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Investigator Global Acne Assessment - Week 2
|
2.17 Units on a scale
Standard Deviation 0.500
|
2.06 Units on a scale
Standard Deviation 0.470
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Investigator Global Acne Assessment - Week 4
|
2.00 Units on a scale
Standard Deviation 0.587
|
1.90 Units on a scale
Standard Deviation 0.583
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Investigator Global Acne Assessment - Week 8
|
1.84 Units on a scale
Standard Deviation 0.669
|
1.73 Units on a scale
Standard Deviation 0.600
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=56 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Investigator Global Acne Assessment - Week 12
|
1.64 Units on a scale
Standard Deviation 0.724
|
1.64 Units on a scale
Standard Deviation 0.589
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
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
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=64 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Redness of Inflammatory Lesions - Week 1
|
4.88 Units on a scale
Standard Deviation 1.222
|
5.05 Units on a scale
Standard Deviation 1.278
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Redness of Inflammatory Lesions - Week 2
|
4.65 Units on a scale
Standard Deviation 1.183
|
4.74 Units on a scale
Standard Deviation 1.202
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Redness of Inflammatory Lesions - Week 4
|
4.49 Units on a scale
Standard Deviation 1.291
|
4.41 Units on a scale
Standard Deviation 1.318
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
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
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Redness of Inflammatory Lesions - Week 8
|
4.30 Units on a scale
Standard Deviation 1.278
|
4.25 Units on a scale
Standard Deviation 1.446
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=56 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Redness of Inflammatory Lesions - Week 12
|
3.96 Units on a scale
Standard Deviation 1.346
|
3.97 Units on a scale
Standard Deviation 1.282
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=64 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Size of Inflammatory Lesions - Week 1
|
4.58 Units on a scale
Standard Deviation 1.298
|
4.83 Units on a scale
Standard Deviation 1.371
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=63 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=60 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Size of Inflammatory Lesions - Week 2
|
4.17 Units on a scale
Standard Deviation 1.129
|
4.56 Units on a scale
Standard Deviation 1.222
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=62 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=56 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Size of Inflammatory Lesions - Week 4
|
4.07 Units on a scale
Standard Deviation 1.273
|
4.15 Units on a scale
Standard Deviation 1.408
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=57 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Size of Inflammatory Lesions - Week 8
|
3.88 Units on a scale
Standard Deviation 1.290
|
3.85 Units on a scale
Standard Deviation 1.606
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Outcome measures
| Measure |
Gel-Cream + Acne Mask
n=56 Participants
Cleanser, Gel-Cream, Acne Mask
|
Acne Mask
n=55 Participants
Cleanser, Acne Mask
|
|---|---|---|
|
Overall Size of Inflammatory Lesions - Week 12
|
3.67 Units on a scale
Standard Deviation 1.305
|
3.59 Units on a scale
Standard Deviation 1.411
|
Adverse Events
Gel-Cream + Acne Mask
Acne Mask
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER