Trial Outcomes & Findings for A Study of S6G5T-3 in the Treatment of Acne Vulgaris (NCT NCT03761784)
NCT ID: NCT03761784
Last Updated: 2021-12-16
Results Overview
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.
COMPLETED
PHASE3
424 participants
Baseline through Week 12
2021-12-16
Participant Flow
Participants were randomized to receive either S6G5T-3 (Encapsulated Benzoyl Peroxide \[E-BPO\] and Encapsulated Tretinoin \[E-ATRA\] Cream, 3%/0.1% \[E-BPO/E-ATRA Cream, 3%/0.1%\]) or vehicle in a 2:1 ratio.
Participant milestones
| Measure |
S6G5T-3
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
281
|
143
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
274
|
139
|
|
Overall Study
COMPLETED
|
249
|
131
|
|
Overall Study
NOT COMPLETED
|
32
|
12
|
Reasons for withdrawal
| Measure |
S6G5T-3
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Parent or Guardian
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Other Than Specified
|
1
|
0
|
Baseline Characteristics
A Study of S6G5T-3 in the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.9 Years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
21.4 Years
STANDARD_DEVIATION 8.62 • n=7 Participants
|
21.1 Years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
102 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
178 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Acne Lesion Count on the Face
Inflammatory Lesions
|
33.5 Lesions
STANDARD_DEVIATION 14.62 • n=5 Participants
|
33.5 Lesions
STANDARD_DEVIATION 14.69 • n=7 Participants
|
33.5 Lesions
STANDARD_DEVIATION 14.63 • n=5 Participants
|
|
Baseline Acne Lesion Count on the Face
Non-Inflammatory lesions
|
48.6 Lesions
STANDARD_DEVIATION 20.24 • n=5 Participants
|
47.1 Lesions
STANDARD_DEVIATION 19.97 • n=7 Participants
|
48.1 Lesions
STANDARD_DEVIATION 20.14 • n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
0 - Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
1 - Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
2 - Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
3 - Moderate
|
251 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
4 - Severe
|
30 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. Multiple imputation (MCMC) was used to impute missing values.
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
|
38.5 percentage of participants
|
11.5 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
|
-21.6 Inflammatory Lesions
Standard Deviation 10.67
|
-14.8 Inflammatory Lesions
Standard Deviation 11.03
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
|
-29.7 Non-Inflammatory Lesions
Standard Deviation 15.26
|
-19.8 Non-Inflammatory Lesions
Standard Deviation 15.84
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
|
-61.6 Percent Change
Standard Deviation 31.38
|
-40.9 Percent Change
Standard Deviation 32.63
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
|
-66.1 Percent Change
Standard Deviation 32.28
|
-43.5 Percent Change
Standard Deviation 32.87
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
|
38.9 percentage of participants
|
18.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
|
42.8 percentage of participants
|
32.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
|
-24.4 Non-Inflammatory Lesions
Standard Deviation 16.44
|
-16.9 Non-Inflammatory Lesions
Standard Deviation 15.60
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
|
-17.2 Inflammatory Lesions
Standard Deviation 12.10
|
-12.5 Inflammatory Lesions
Standard Deviation 11.61
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
|
-18.5 Non-Inflammatory Lesions
Standard Deviation 14.16
|
-13.4 Non-Inflammatory Lesions
Standard Deviation 13.99
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Outcome measures
| Measure |
S6G5T-3
n=281 Participants
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=143 Participants
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
|
-13.5 Inflammatory Lesions
Standard Deviation 10.32
|
-9.8 Inflammatory Lesions
Standard Deviation 10.28
|
Adverse Events
S6G5T-3
S6G5T-8 Vehicle Cream
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
S6G5T-3
n=274 participants at risk
Participants topically applied S6G5T-3, once daily to face for 12 weeks.
|
S6G5T-8 Vehicle Cream
n=139 participants at risk
Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
General disorders
Application site pain
|
12.0%
33/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
0.00%
0/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
|
General disorders
Application site dryness
|
6.2%
17/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
0.72%
1/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
|
General disorders
Application site erythema
|
5.1%
14/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
0.00%
0/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
|
General disorders
Application site exfoliation
|
5.1%
14/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
0.00%
0/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
|
General disorders
Application site dermatitis
|
1.5%
4/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
0.72%
1/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
|
General disorders
Application site irritation
|
1.5%
4/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
0.00%
0/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
6/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
2.2%
3/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
|
Nervous system disorders
Headache
|
1.1%
3/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
0.72%
1/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/274 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
1.4%
2/139 • Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER