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

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ClinicalTrials.gov Identifier: NCT02932267
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : November 15, 2019
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Galderma R&D

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).

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene 0.3% / BPO 2.5% gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : January 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Adapalene

Arm Intervention/treatment
Experimental: Adapalene / BPO gel
Adapalene 0.3% / BPO 2.5% gel, once daily in the evening
Drug: 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
Other Name: Epiduo Forte / Tactupump gel

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932267

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United States, Texas
Austin, Texas, United States, 78759
Phoenix, Mauritius
Singapore, Singapore
Sponsors and Collaborators
Galderma R&D
  Study Documents (Full-Text)

Documents provided by Galderma R&D:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02932267    
Other Study ID Numbers: RD.03.SPR.110232
First Posted: October 13, 2016    Key Record Dates
Results First Posted: November 15, 2019
Last Update Posted: February 18, 2021
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galderma R&D:
Dark skin
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents