Clinical trial NCT02932267: Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne
Official title: Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne
Dark skin
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire
timeFrame: At week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dermresearch
state: Texas
city: Phoenix
country: Mauritius
facility: CIDP
city: Singapore
country: Singapore
facility: CIDP
Study officials:
References:
citation: DuBois J, Ong GCW, Petkar G, Almeida LMC, Chavda R, Kerrouche N, Alexis AF. Patient-Reported Outcomes in Acne Patients With Skin of Color Using Adapalene 0.3%-Benzoyl Peroxide 2.5%: A Prospective Real-World Study. J Drugs Dermatol. 2019 Jun 1;18(5):514.