Acne Vulgaris
Conditions
Keywords
Acne, Dark skin
Brief summary
This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face. All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face. The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).
Interventions
DRUGAdapalene 0.3% / BPO 2.5% gel
Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by: 1. Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and 2. A minimum of 25-100 inflammatory lesions (papules and pustules); and 3. A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and 4. No more than two acne nodules (≥ 1 cm), * Subject with skin phototype IV to VI on Fitzpatrick skin phototype scale, * Subjects from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American,
Exclusion criteria
* Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment, * Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea * Female subject who is pregnant, lactating or planning a pregnancy during the trial, * Subjects having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, dapsone, hydroxyacids, Zinc containing treatments, antiseptics, other anti-inflammatory products or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Wax epilation (2 weeks); Photodynamic therapy (6 weeks); Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne (3 months). * Subjects having received at least one of the following systemic treatments: Corticosteroids, tetracyclines, other antibiotics (except penicillin) (1 month); Oral retinoids/isotretinoin/ anti-androgens / Cyproterone acetate / Chlormadinone acetate (6 months); Spironolactone/ Drospirenone (3 months); Immunomodulators (3 months) and Oral contraceptives/ oral dapsone for acne(1 month).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire | At week 12 | % of subjects satisfied to very satisfied with study treatment at week 12 |
Countries
Mauritius, Singapore, United States
Participant flow
Pre-assignment details
Wash-out period for topical treatment or procedures of 1 week to 3 months and for systemic treatment for 1 month to 3 months, depending on treatment
Participants by arm
| Arm | Count |
|---|---|
| Adapalene / BPO Gel Adapalene 0.3% / BPO 2.5% gel, once daily in the evening
Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Adapalene / BPO Gel |
|---|---|
| Age, Categorical <=18 years | 21 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 20.9 years STANDARD_DEVIATION 6.4 |
| Race/Ethnicity, Customized Asian | 20 Participants |
| Race/Ethnicity, Customized Black/African-American | 17 Participants |
| Race/Ethnicity, Customized Latin American | 13 Participants |
| Region of Enrollment Mauritius | 16 participants |
| Region of Enrollment Singapore | 16 participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 26 Participants |
| Skin phototype Phototype IV | 37 Participants |
| Skin phototype Phototype V | 11 Participants |
| Skin phototype Phototype VI | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 9 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire
% of subjects satisfied to very satisfied with study treatment at week 12
Time frame: At week 12
Population: Intent-to-treat (ITT) population. Here 'N' (number analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adapalene / BPO Gel | Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire | 36 Participants |