Acne
Conditions
Keywords
Acne
Brief summary
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
Detailed description
This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris
Interventions
DRUGAdapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Topical Gel to the face, once daily in the evening for 24 weeks.
DRUGVehicle Gel
Topical Gel to the face, once daily in the evening for 24 weeks.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)
Exclusion criteria
* Female Subjects who are pregnant, nursing or planning a pregnancy during the study * Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance Success for Total Lesions at Week 24 | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance Success for Inflamatory Lesions at Week 24 | Week 24 | 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. |
| Maintenance Success for Non-inflammatory Lesions at Week 24 | Week 24 | 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. |
| Investigator Global Assessment (IGA) Maintenance Success at Week 24 | Baseline, Week 24 | 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 |
| Percent of Subjects With Adverse Events | Up to 24 weeks | All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent |
Countries
Canada, Puerto Rico, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Adapalene-BPO Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel | 123 |
| Vehicle Vehicle Gel | 120 |
| Total | 243 |
Baseline characteristics
| Characteristic | Adapalene-BPO | Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 76 Participants | 84 Participants | 160 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 36 Participants | 83 Participants |
| Age, Continuous | 19.1 years STANDARD_DEVIATION 5.89 | 18.2 years STANDARD_DEVIATION 5.23 | 18.6 years STANDARD_DEVIATION 5.58 |
| Region of Enrollment Canada | 26 participants | 28 participants | 54 participants |
| Region of Enrollment Puerto Rico | 13 participants | 13 participants | 26 participants |
| Region of Enrollment United States | 84 participants | 79 participants | 163 participants |
| Sex: Female, Male Female | 58 Participants | 53 Participants | 111 Participants |
| Sex: Female, Male Male | 65 Participants | 67 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 123 | 27 / 120 |
| serious Total, serious adverse events | 1 / 123 | 1 / 120 |
Outcome results
Primary
Maintenance Success for Total Lesions at Week 24
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.
Time frame: Week 24
Population: ITT - Worst-case (Any missing data at Week 24 is considered as a failure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene-BPO | Maintenance Success for Total Lesions at Week 24 | 78.9 percent of subjects |
| Vehicle | Maintenance Success for Total Lesions at Week 24 | 45.8 percent of subjects |
Secondary
Investigator Global Assessment (IGA) Maintenance Success at Week 24
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
Time frame: Baseline, Week 24
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene-BPO | Investigator Global Assessment (IGA) Maintenance Success at Week 24 | 70.7 percent of subjects |
| Vehicle | Investigator Global Assessment (IGA) Maintenance Success at Week 24 | 34.2 percent of subjects |
Secondary
Maintenance Success for Inflamatory Lesions at Week 24
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.
Time frame: Week 24
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene-BPO | Maintenance Success for Inflamatory Lesions at Week 24 | 78 percent of subjects |
| Vehicle | Maintenance Success for Inflamatory Lesions at Week 24 | 48.3 percent of subjects |
Secondary
Maintenance Success for Non-inflammatory Lesions at Week 24
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.
Time frame: Week 24
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene-BPO | Maintenance Success for Non-inflammatory Lesions at Week 24 | 78 percent of subjects |
| Vehicle | Maintenance Success for Non-inflammatory Lesions at Week 24 | 43.3 percent of subjects |
Secondary
Percent of Subjects With Adverse Events
All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent
Time frame: Up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene-BPO | Percent of Subjects With Adverse Events | 41.5 percent of subjects |
| Vehicle | Percent of Subjects With Adverse Events | 29.2 percent of subjects |