Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne
| Status: | Completed |
|---|---|
| Conditions: | Acne, Acne, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 9/13/2018 |
| Start Date: | February 2, 2017 |
| End Date: | January 10, 2018 |
Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects
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).
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).
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).
We found this trial at
2
sites
Click here to add this to my saved trials
