Acne Vulgaris
Conditions
Brief summary
The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.
Interventions
Apply adapalene BPO gel once daily in the evening for 12 weeks
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, aged 16 to 25 years inclusive; * Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3; * A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose); * Subjects who agree to be photographed at each visit; * Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study
Exclusion criteria
* Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment; * Subjects with a wash-out period for topical acne treatment on the face less than 30 days * Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months; * Subjects who are currently being treated with antibiotics; * Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.); * Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 | 12 weeks | Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. | Week 12 | Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12. |
| Number of Participants With Tolerability Assessments Resulting in an Adverse Event | 12 weeks | Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst. |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: First subject was enrolled on October 7, 2010 and the last subject was enrolled on October 12, 2010. Types of location: Investigative site was located at a research center.
Pre-assignment details
Wash-out period up to baseline was 30 days for topical and systemic acne treatments with the exception of isotretinoin, which had a wash-out period of 4 months.
Participants by arm
| Arm | Count |
|---|---|
| Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel |
|---|---|
| Age, Continuous | 17.5 years STANDARD_DEVIATION 1.68 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.
Time frame: 12 weeks
Population: Modified ITT (subjects with a baseline and week 12 visit)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel | Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 | 18 participants |
Secondary
Number of Participants With Tolerability Assessments Resulting in an Adverse Event
Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.
Time frame: 12 weeks
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel | Number of Participants With Tolerability Assessments Resulting in an Adverse Event | 2 participants |
Secondary
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.
Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.
Time frame: Week 12
Population: Modified ITT (subjects with a baseline and week 12 visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. | Inflammatory Lesions | -44.1 percent change from baseline | Standard Deviation 34.79 |
| Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. | Noninflammatory Lesions | -57.1 percent change from baseline | Standard Deviation 19.83 |
| Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. | Total Lesions | -49.7 percent change from baseline | Standard Deviation 24.06 |