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Completed

NCT Number: NCT02932267

Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne

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).

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIDP, Phoenix, Mauritius

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:
  • Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and
  • A minimum of 25-100 inflammatory lesions (papules and pustules); and
  • A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and
  • 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).

Treatment and study plan

Adapalene 0.3% / BPO 2.5% gel

Drug

Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

Other names: Epiduo Forte / Tactupump gel

Primary outcomes

  1. Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire

    Time frame: At week 12

    % of subjects satisfied to very satisfied with study treatment at week 12

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects

Acronym: EDeN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2016
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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