Acne
Conditions
Keywords
Acne
Brief summary
The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.
Interventions
DRUGAdapalene BPO Gel standard daily overnight application
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
DRUGAdapalene-BPO 3-hour daily application before bedtime
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
DRUGAdapalene-BPO Gel every other day application
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
DRUGAdapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Male or female Subjects of any race, aged 12 to 35 years inclusive * Subjects with mild or moderate facial acne vulgaris * Subjects with skin phototype I to IV
Exclusion criteria
* Subjects with more than 1 nodules or cysts on the face, * Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. | Week 4 | Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit \[None=0, Mild=1, Moderate=2 and Severe=3\]. In consequence, it ranges from 0 \[better outcome\] to 12 \[worse outcome\]and was calculated for each study visit. |
Countries
Canada
Participant flow
Recruitment details
Recruitment period: 23 APR 2009 to 09 SEP 2009 in three private practice Canadian centres. Two centers used a central IRB, and the other used a local IRB.
Participants by arm
| Arm | Count |
|---|---|
| Adapalene-BPO Gel 3h Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks | 32 |
| Adapalene-BPO Gel EoD Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks | 32 |
| Adapalene-BPO Gel Cetaphil Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks | 29 |
| Adapalene-BPO Gel StD Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week | 30 |
| Total | 123 |
Baseline characteristics
| Characteristic | Adapalene-BPO Gel EoD | Adapalene-BPO Gel Cetaphil | Adapalene-BPO Gel 3h | Adapalene-BPO Gel StD | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 13 Participants | 15 Participants | 14 Participants | 57 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 16 Participants | 17 Participants | 16 Participants | 66 Participants |
| Age, Continuous | 20.4 years STANDARD_DEVIATION 6.39 | 20.9 years STANDARD_DEVIATION 6.83 | 20.2 years STANDARD_DEVIATION 6.5 | 20.8 years STANDARD_DEVIATION 6.31 | 20.6 years STANDARD_DEVIATION 6.43 |
| Region of Enrollment Canada | 32 participants | 29 participants | 32 participants | 30 participants | 123 participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 20 Participants | 16 Participants | 71 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 12 Participants | 14 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 32 | 5 / 32 | 8 / 29 | 6 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 29 | 0 / 30 |
Outcome results
Primary
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit \[None=0, Mild=1, Moderate=2 and Severe=3\]. In consequence, it ranges from 0 \[better outcome\] to 12 \[worse outcome\]and was calculated for each study visit.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapalene-BPO Gel 3h | Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. | 4.23 Scores on a scale | Standard Deviation 2.04 |
| Adapalene-BPO Gel EoD | Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. | 3.06 Scores on a scale | Standard Deviation 1.92 |
| Adapalene-BPO Gel Cetaphil | Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. | 3.25 Scores on a scale | Standard Deviation 2.05 |
| Adapalene-BPO Gel StD | Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. | 4.13 Scores on a scale | Standard Deviation 2.45 |