Trial Outcomes & Findings for Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance (NCT NCT00687908)
NCT ID: NCT00687908
Last Updated: 2021-02-18
Results Overview
Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.
COMPLETED
PHASE3
243 participants
Week 24
2021-02-18
Participant Flow
Recruitment period: 12 NOV 2008 to 09 FEB 2009 in thirty-four centers (29 in the USA and 5 in Canada) public or private practices. Twenty-four USA centers and four Candadian centers used a central IRB, and the others used a local IRB.
Participant milestones
| Measure |
Adapalene-BPO
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
Vehicle Gel
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
120
|
|
Overall Study
COMPLETED
|
105
|
78
|
|
Overall Study
NOT COMPLETED
|
18
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
Baseline characteristics by cohort
| Measure |
Adapalene-BPO
n=123 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
n=120 Participants
Vehicle Gel
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
76 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
19.1 years
STANDARD_DEVIATION 5.89 • n=99 Participants
|
18.2 years
STANDARD_DEVIATION 5.23 • n=107 Participants
|
18.6 years
STANDARD_DEVIATION 5.58 • n=206 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=99 Participants
|
79 participants
n=107 Participants
|
163 participants
n=206 Participants
|
|
Region of Enrollment
Puerto Rico
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
26 participants
n=99 Participants
|
28 participants
n=107 Participants
|
54 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: ITT - Worst-case (Any missing data at Week 24 is considered as a failure)
Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.
Outcome measures
| Measure |
Adapalene-BPO
n=123 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
n=120 Participants
Vehicle Gel
|
|---|---|---|
|
Maintenance Success for Total Lesions at Week 24
|
78.9 percent of subjects
|
45.8 percent of subjects
|
SECONDARY outcome
Timeframe: Week 24Population: ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)
Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.
Outcome measures
| Measure |
Adapalene-BPO
n=123 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
n=120 Participants
Vehicle Gel
|
|---|---|---|
|
Maintenance Success for Inflamatory Lesions at Week 24
|
78 percent of subjects
|
48.3 percent of subjects
|
SECONDARY outcome
Timeframe: Week 24Population: ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)
Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.
Outcome measures
| Measure |
Adapalene-BPO
n=123 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
n=120 Participants
Vehicle Gel
|
|---|---|---|
|
Maintenance Success for Non-inflammatory Lesions at Week 24
|
78 percent of subjects
|
43.3 percent of subjects
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)
IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade. IGA grade: 0 Clear:Residual hyperpigmentation \& erythema may be present 1. Almost Clear:A few scattered comedones \& a few small papules. 2. Mild:Some comedones \& some papules and pustules. No nodules present 3. Moderate:Many comedones, papules \& pustules. One nodule may be present 4. Severe:Covered with comedones, numerous papules \& pustules \& few nodules \& cysts may be present 5. Very severe:Highly inflammatory acne covering the face; with nodules \& cysts present
Outcome measures
| Measure |
Adapalene-BPO
n=123 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
n=120 Participants
Vehicle Gel
|
|---|---|---|
|
Investigator Global Assessment (IGA) Maintenance Success at Week 24
|
70.7 percent of subjects
|
34.2 percent of subjects
|
SECONDARY outcome
Timeframe: Up to 24 weeksAll participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent
Outcome measures
| Measure |
Adapalene-BPO
n=123 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
n=120 Participants
Vehicle Gel
|
|---|---|---|
|
Percent of Subjects With Adverse Events
|
41.5 percent of subjects
|
29.2 percent of subjects
|
Adverse Events
Adapalene-BPO
Vehicle
Serious adverse events
| Measure |
Adapalene-BPO
n=123 participants at risk
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
n=120 participants at risk
Vehicle Gel
|
|---|---|---|
|
Nervous system disorders
Bipolar disorder
|
0.81%
1/123 • Number of events 1 • 6 months
|
0.00%
0/120 • 6 months
|
|
Infections and infestations
Pilonidal abscess
|
0.00%
0/123 • 6 months
|
0.83%
1/120 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Adapalene-BPO
n=123 participants at risk
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
|
Vehicle
n=120 participants at risk
Vehicle Gel
|
|---|---|---|
|
Nervous system disorders
Headache
|
4.1%
5/123 • Number of events 5 • 6 months
|
2.5%
3/120 • Number of events 3 • 6 months
|
|
Infections and infestations
Influenza
|
3.3%
4/123 • Number of events 4 • 6 months
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
8/123 • Number of events 10 • 6 months
|
10.0%
12/120 • Number of events 12 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
2.4%
3/123 • Number of events 3 • 6 months
|
0.00%
0/120 • 6 months
|
|
Infections and infestations
Pharyngitis
|
3.3%
4/123 • Number of events 4 • 6 months
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.3%
4/123 • Number of events 4 • 6 months
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.4%
3/123 • Number of events 3 • 6 months
|
1.7%
2/120 • Number of events 3 • 6 months
|
|
General disorders
Pyrexia
|
3.3%
4/123 • Number of events 4 • 6 months
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Infections and infestations
Sinusitis
|
3.3%
4/123 • Number of events 4 • 6 months
|
1.7%
2/120 • Number of events 2 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
4/123 • Number of events 5 • 6 months
|
3.3%
4/120 • Number of events 4 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
- Publication restrictions are in place
Restriction type: OTHER