Acne VulgarisPhase 3EDeNNCT02932267
Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne
A Phase 3 study testing Adapalene 0.3% / BPO 2.5% gel in people with Acne Vulgaris, run by Galderma R&D at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Adapalene 0.3% / BPO 2.5% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 2 Feb 2017to 10 Jan 2018
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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).
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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).
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene 0.3% / BPO 2.5% gel
- Keywords
- Acne, Dark skin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene 0.3% / BPO 2.5% gelDrug
Also called Epiduo Forte / Tactupump gel
Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adapalene / BPO gel | Experimental | Adapalene 0.3% / BPO 2.5% gel, once daily in the evening Receives: Drug: Adapalene 0.3% / BPO 2.5% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire
% of subjects satisfied to very satisfied with study treatment at week 12
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start2 Feb 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932267
- Sponsor's protocol ID
- RD.03.SPR.110232
- Acronym
- EDeN
- Status last verified
- Dec 2019
- First submitted
- 11 Oct 2016
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 31251543