Trial Outcomes & Findings for A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris (NCT NCT00421993)
NCT ID: NCT00421993
Last Updated: 2021-02-18
Results Overview
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1670 participants
Primary outcome timeframe
at week 12
Results posted on
2021-02-18
Participant Flow
Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007. Types of locations: Dermatology Clinics, Dermatology Research Centers.
The specified washout period up to Baseline for TOPICAL facial treatments was 1 week (light therapy/exfoliation/blackhead removal) or 2 weeks (anti-inflammatory drugs/salicylic acid/steroids/antibiotics/laser) and for SYSTEMIC medications was 2 weeks (anti-inflammatory drugs), 4 Weeks (steroids/antibiotics), or 6 months (anti-acne/contraceptives).
Participant milestones
| Measure |
Adapalene/Benzoyl Peroxide Gel
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
419
|
418
|
415
|
418
|
|
Overall Study
COMPLETED
|
366
|
369
|
363
|
361
|
|
Overall Study
NOT COMPLETED
|
53
|
49
|
52
|
57
|
Reasons for withdrawal
| Measure |
Adapalene/Benzoyl Peroxide Gel
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
22
|
23
|
23
|
24
|
|
Overall Study
Lost to Follow-up
|
18
|
19
|
22
|
20
|
|
Overall Study
Adverse Event
|
11
|
1
|
6
|
4
|
|
Overall Study
Protocol Violation
|
2
|
2
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
0
|
5
|
|
Overall Study
Pregnancy
|
0
|
1
|
1
|
2
|
|
Overall Study
Subject transportation issues
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 Participants
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 Participants
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 Participants
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 Participants
Topical Gel Vehicle
|
Total
n=1670 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
19.5 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
18.5 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
18.9 years
STANDARD_DEVIATION 6.96 • n=5 Participants
|
19.2 years
STANDARD_DEVIATION 7.23 • n=4 Participants
|
19 years
STANDARD_DEVIATION 6.81 • n=21 Participants
|
|
Age, Customized
12-17 years
|
233 participants
n=5 Participants
|
241 participants
n=7 Participants
|
244 participants
n=5 Participants
|
243 participants
n=4 Participants
|
961 participants
n=21 Participants
|
|
Age, Customized
Between 18 and 64 years
|
186 participants
n=5 Participants
|
177 participants
n=7 Participants
|
171 participants
n=5 Participants
|
175 participants
n=4 Participants
|
709 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
236 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
244 Participants
n=4 Participants
|
939 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
731 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
185 participants
n=5 Participants
|
185 participants
n=7 Participants
|
179 participants
n=5 Participants
|
185 participants
n=4 Participants
|
734 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
102 participants
n=5 Participants
|
100 participants
n=7 Participants
|
100 participants
n=5 Participants
|
101 participants
n=4 Participants
|
403 participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
132 participants
n=5 Participants
|
133 participants
n=7 Participants
|
136 participants
n=5 Participants
|
132 participants
n=4 Participants
|
533 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: at week 12Population: Intention to treat (ITT), last observation carried forward (LOCF).
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 Participants
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 Participants
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 Participants
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 Participants
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Success Rate on the Investigator's Global Assessment
|
37.9 Percentage of participants
|
21.8 Percentage of participants
|
26.7 Percentage of participants
|
17.9 Percentage of participants
|
PRIMARY outcome
Timeframe: from Baseline to week 12Population: ITT, LOCF
Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 Participants
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 Participants
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 Participants
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 Participants
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Changes in Inflammatory Lesion Counts
|
-18 Lesion count
Interval -49.0 to 50.0
|
-15 Lesion count
Interval -49.0 to 50.0
|
-16 Lesion count
Interval -63.0 to 38.0
|
-12 Lesion count
Interval -47.0 to 95.0
|
PRIMARY outcome
Timeframe: from Baseline to week 12Population: ITT, LOCF
Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 Participants
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 Participants
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 Participants
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 Participants
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Changes in Noninflammatory Lesion Counts
|
-28 Lesion count
Interval -93.0 to 108.0
|
-24 Lesion count
Interval -96.0 to 44.0
|
-23 Lesion count
Interval -87.0 to 61.0
|
-18 Lesion count
Interval -82.0 to 69.0
|
SECONDARY outcome
Timeframe: at week 12Population: ITT, LOCF
Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 Participants
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 Participants
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 Participants
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 Participants
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Percent Change in Inflammatory Lesion Counts
|
-61.7 Percent change
Standard Deviation 33.9
|
-50.1 Percent change
Standard Deviation 39.4
|
-52.2 Percent change
Standard Deviation 39.4
|
-40.8 Percent change
Standard Deviation 41.1
|
SECONDARY outcome
Timeframe: at week 12Population: ITT, LOCF
Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 Participants
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 Participants
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 Participants
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 Participants
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Percent Change in Noniflammatory Lesion Counts
|
-55.6 Percent change
Standard Deviation 35.3
|
-46.0 Percent change
Standard Deviation 33.7
|
-44.1 Percent change
Standard Deviation 37.3
|
-32.3 Percent change
Standard Deviation 39.5
|
SECONDARY outcome
Timeframe: at week 12Population: ITT, LOCF
Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 Participants
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 Participants
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 Participants
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 Participants
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Percent Change in Total Lesion Counts
|
-57.7 Percent change
Standard Deviation 31.9
|
-47.5 Percent change
Standard Deviation 31.3
|
-47.2 Percent change
Standard Deviation 32.7
|
-35.2 Percent change
Standard Deviation 36
|
Adverse Events
Adapalene/Benzoyl Peroxide Gel
Serious events: 3 serious events
Other events: 90 other events
Deaths: 0 deaths
Adapalene Gel
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Benzoyl Peroxide Gel
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Gel Vehicle
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 participants at risk
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 participants at risk
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 participants at risk
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 participants at risk
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Infections and infestations
Furuncle
|
0.24%
1/419 • Number of events 1
|
0.00%
0/418
|
0.00%
0/415
|
0.00%
0/418
|
|
Infections and infestations
Appendicitis
|
0.24%
1/419 • Number of events 1
|
0.00%
0/418
|
0.00%
0/415
|
0.00%
0/418
|
|
Infections and infestations
Abscess limb
|
0.00%
0/419
|
0.00%
0/418
|
0.00%
0/415
|
0.24%
1/418 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.24%
1/419 • Number of events 1
|
0.00%
0/418
|
0.00%
0/415
|
0.00%
0/418
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/419
|
0.00%
0/418
|
0.00%
0/415
|
0.24%
1/418 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/419
|
0.00%
0/418
|
0.24%
1/415 • Number of events 1
|
0.00%
0/418
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/419
|
0.24%
1/418 • Number of events 1
|
0.00%
0/415
|
0.00%
0/418
|
Other adverse events
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=419 participants at risk
Adapalene/Benzoyl Peroxide Topical Gel
|
Adapalene Gel
n=418 participants at risk
Adapalene Topical Gel
|
Benzoyl Peroxide Gel
n=415 participants at risk
Benzoyl Peroxide Topical Gel
|
Gel Vehicle
n=418 participants at risk
Topical Gel Vehicle
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
21.5%
90/419 • Number of events 93
|
14.4%
60/418 • Number of events 61
|
8.4%
35/415 • Number of events 37
|
5.3%
22/418 • Number of events 22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the expiration of twenty-four (24) months after the completion of the Study, Investigator shall have the right to publish the results of the Study; provided, however that Sponsor shall have the right to review any proposed publication generated from the Study prior to publication or presentation. The Sponsor shall have the absolute right to refuse the publication altogether, to delay it or to amend its contents as it deems fit.
- Publication restrictions are in place
Restriction type: OTHER