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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 : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma

Tracking Information
First Submitted Date  ICMJE October 11, 2016
First Posted Date  ICMJE October 13, 2016
Results First Submitted Date  ICMJE September 26, 2018
Results First Posted Date  ICMJE November 15, 2019
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE February 2, 2017
Actual Primary Completion Date January 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
Subject 's overall satisfaction [ Time Frame: At week 12 ]
% of subjects satisfied to very satisfied with study treatment at week 12
Change History Complete list of historical versions of study NCT02932267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne
Official Title  ICMJE Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Adapalene / BPO gel
Adapalene 0.3% / BPO 2.5% gel, once daily in the evening
Intervention: Drug: Adapalene 0.3% / BPO 2.5% gel
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2016)
60
Actual Study Completion Date  ICMJE January 10, 2018
Actual Primary Completion Date January 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mauritius,   Singapore,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT02932267
Other Study ID Numbers  ICMJE RD.03.SPR.110232
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP