Trial Outcomes & Findings for Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris (NCT NCT00422240)
NCT ID: NCT00422240
Last Updated: 2024-04-15
Results Overview
Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1668 participants
Primary outcome timeframe
At Week 12
Results posted on
2024-04-15
Participant Flow
A total of 1668 participants with acne vulgaris were randomized, administered and enrolled.
Participant milestones
| Measure |
Adapalene/Benzoyl Peroxide Gel
Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
415
|
420
|
415
|
418
|
|
Overall Study
COMPLETED
|
347
|
363
|
372
|
347
|
|
Overall Study
NOT COMPLETED
|
68
|
57
|
43
|
71
|
Reasons for withdrawal
| Measure |
Adapalene/Benzoyl Peroxide Gel
Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
0
|
1
|
|
Overall Study
Adverse Event
|
11
|
4
|
5
|
2
|
|
Overall Study
Subject request
|
21
|
17
|
18
|
30
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
31
|
32
|
19
|
34
|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
3
|
1
|
1
|
2
|
Baseline Characteristics
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=415 Participants
Participants were treated with adapalene 0.1 % (W/W)/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 Participants
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 Participants
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=418 Participants
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
Total
n=1668 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
18.7 years
STANDARD_DEVIATION 7.14 • n=5 Participants
|
17.9 years
STANDARD_DEVIATION 5.40 • n=7 Participants
|
18.4 years
STANDARD_DEVIATION 6.55 • n=5 Participants
|
18.0 years
STANDARD_DEVIATION 6.09 • n=4 Participants
|
18.2 years
STANDARD_DEVIATION 6.33 • n=21 Participants
|
|
Sex: Female, Male
Female
|
210 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
222 Participants
n=4 Participants
|
856 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
812 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
273 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
1082 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
66 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
277 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
67 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
270 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Week 12Population: ITT (Intent-To-Treat) Population included all treated participants. Here, Overall Number of Participants Analyzed = Participants with available data for this outcome measure.
Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=415 Participants
Participants were treated with adapalene 0.1 % \[weight by weight (W/W))\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 Participants
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 Participants
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=417 Participants
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)
|
30.1 percentage of participants
|
19.8 percentage of participants
|
22.2 percentage of participants
|
11.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITT Population included all treated participants.
Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=415 Participants
Participants were treated with adapalene 0.1 % \[weight by weight (W/W))\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 Participants
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 Participants
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=418 Participants
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Change in Inflammatory Lesion Count From Baseline to Week 12
Baseline
|
27.0 lesions
Interval 23.0 to 35.0
|
27.0 lesions
Interval 23.0 to 34.0
|
27.0 lesions
Interval 23.0 to 34.0
|
27.0 lesions
Interval 22.0 to 35.0
|
|
Change in Inflammatory Lesion Count From Baseline to Week 12
Change at Week 12
|
-16.0 lesions
Interval -22.0 to -10.0
|
-14.0 lesions
Interval -20.0 to -7.0
|
-16.0 lesions
Interval -21.0 to -7.0
|
-10.0 lesions
Interval -16.0 to -2.0
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITT Population included all treated participants.
Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=415 Participants
Participants were treated with adapalene 0.1 % \[weight by weight (W/W))\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 Participants
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 Participants
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=418 Participants
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Change in Noninflammatory Lesion Count From Baseline to Week 12
Change at Week 12
|
-24.0 lesions
Interval -35.0 to -13.0
|
-22.0 lesions
Interval -34.0 to -11.0
|
-20.0 lesions
Interval -32.0 to -7.0
|
-14.0 lesions
Interval -25.0 to -1.0
|
|
Change in Noninflammatory Lesion Count From Baseline to Week 12
Baseline
|
44.0 lesions
Interval 36.0 to 62.0
|
47.0 lesions
Interval 37.0 to 61.0
|
46.0 lesions
Interval 36.0 to 63.0
|
46.0 lesions
Interval 36.0 to 62.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT Population included all treated participants.
The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=415 Participants
Participants were treated with adapalene 0.1 % \[weight by weight (W/W))\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 Participants
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 Participants
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=418 Participants
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
|
-55.33 percent change
Standard Deviation 34.678
|
-41.68 percent change
Standard Deviation 41.855
|
-47.61 percent change
Standard Deviation 38.415
|
-30.23 percent change
Standard Deviation 41.661
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT Population included all treated participants.
The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=415 Participants
Participants were treated with adapalene 0.1 % \[weight by weight (W/W))\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 Participants
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 Participants
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=418 Participants
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12
|
-48.15 percent change
Standard Deviation 35.428
|
-40.75 percent change
Standard Deviation 40.822
|
-37.23 percent change
Standard Deviation 39.758
|
-23.22 percent change
Standard Deviation 48.613
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT Population included all treated participants.
The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=415 Participants
Participants were treated with adapalene 0.1 % \[weight by weight (W/W))\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 Participants
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 Participants
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=418 Participants
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Total Lesion Counts at Week 12
|
-49.97 percent change in lesions
Standard Deviation 31.966
|
-41.29 percent change in lesions
Standard Deviation 36.133
|
-41.23 percent change in lesions
Standard Deviation 33.794
|
-26.06 percent change in lesions
Standard Deviation 38.714
|
Adverse Events
Adapalene/Benzoyl Peroxide Gel
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Adapalene Gel, 0.1%
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Benzoyl Peroxide Gel 2.5%
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Gel Vehicle
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=415 participants at risk
Participants were treated with adapalene 0.1 % (W/W)/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 participants at risk
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 participants at risk
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=418 participants at risk
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.24%
1/415 • Number of events 1 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.24%
1/420 • Number of events 1 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/418 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
|
Psychiatric disorders
Suicide attempt
|
0.24%
1/415 • Number of events 1 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/420 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/418 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.24%
1/420 • Number of events 1 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/418 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
|
Infections and infestations
Abscess
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.24%
1/420 • Number of events 1 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/418 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.24%
1/420 • Number of events 1 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/418 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/420 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.00%
0/415 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
0.24%
1/418 • Number of events 1 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
Other adverse events
| Measure |
Adapalene/Benzoyl Peroxide Gel
n=415 participants at risk
Participants were treated with adapalene 0.1 % (W/W)/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
|
Adapalene Gel, 0.1%
n=420 participants at risk
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
|
Benzoyl Peroxide Gel 2.5%
n=415 participants at risk
Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
|
Gel Vehicle
n=418 participants at risk
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
28/415 • Number of events 28 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
5.0%
21/420 • Number of events 21 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
2.2%
9/415 • Number of events 9 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
3.1%
13/418 • Number of events 13 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
16/415 • Number of events 16 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
7.1%
30/420 • Number of events 30 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
4.8%
20/415 • Number of events 20 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
5.0%
21/418 • Number of events 21 • From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place