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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Adapalene 0.3% / BPO 2.5% gel

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, Dark skin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Dermresearch
CIDP
CIDP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adapalene / BPO gel

Arm Description

Adapalene 0.3% / BPO 2.5% gel, once daily in the evening

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02932267

First Posted

October 11, 2016

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02932267

Brief Title

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

Acronym

EDeN

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

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

February 2, 2017 (Actual)

Primary Completion Date

January 10, 2018 (Actual)

Study Completion Date

January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

Acne, Dark skin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adapalene / BPO gel

Arm Type

Experimental

Arm Description

Adapalene 0.3% / BPO 2.5% gel, once daily in the evening

Intervention Type

Drug

Intervention Name(s)

Adapalene 0.3% / BPO 2.5% gel

Other Intervention Name(s)

Epiduo Forte / Tactupump gel

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

Dermresearch

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

CIDP

City

Phoenix

Country

Mauritius

Facility Name

CIDP

City

Singapore

Country

Singapore

12. IPD Sharing Statement

Citations:

PubMed Identifier

31251543

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.

Results Reference

derived

Learn more about this trial

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

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