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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02932267
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Arm: 1
• Actual Duration (Months): 11.2
• Patients Per Site: 16.7
• Patients Per Site Per Month: 1.5

Study Details

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).

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

Study Design

• Study Type: Interventional
• 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: Feb 2, 2017
• Actual Primary Completion Date: Jan 10, 2018
• Actual Study Completion Date: Jan 10, 2018

Arms and Interventions

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 Names: Epiduo Forte / Tactupump gel

Outcome Measures

Primary Outcome Measures

1. Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire [At week 12]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermresearch	Austin	Texas	United States	78759
2	CIDP	Phoenix		Mauritius
3	CIDP	Singapore		Singapore

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan: Version for USA - Mar 23, 2017

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02932267
• Other Study ID Numbers: RD.03.SPR.110232
• First Posted: Oct 13, 2016
• Last Update Posted: Feb 18, 2021
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Galderma R&D: Acne; Dark skin
• Additional relevant MeSH terms: Acne Vulgaris; Adapalene

Study Results

Participant Flow

Pre-assignment Detail	Wash-out period for topical treatment or procedures of 1 week to 3 months and for systemic treatment for 1 month to 3 months, depending on treatment

Arm/Group Title	Adapalene / BPO Gel
Arm/Group Description	Adapalene 0.3% / BPO 2.5% gel, once daily in the evening 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
Period Title: Overall Study
STARTED	50
COMPLETED	42
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Adapalene / BPO Gel
Arm/Group Description	Adapalene 0.3% / BPO 2.5% gel, once daily in the evening 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
Overall Participants	50
Age (Count of Participants)
<=18 years	21 42%
Between 18 and 65 years	29 58%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.9 (6.4)
Sex: Female, Male (Count of Participants)
Female	24 48%
Male	26 52%
Race/Ethnicity, Customized (Count of Participants)
Asian	20 40%
Latin American	13 26%
Black/African-American	17 34%
Region of Enrollment (participants) [Number]
Singapore	16 32%
United States	18 36%
Mauritius	16 32%
Skin phototype (Count of Participants)
Phototype IV	37 74%
Phototype V	11 22%
Phototype VI	2 4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Here 'N' (number analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Adapalene / BPO Gel
Arm/Group Description	Adapalene 0.3% / BPO 2.5% gel, once daily in the evening 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
Measure Participants	47
Count of Participants [Participants]	36 72%

Adverse Events

Time Frame	Up to 16 Weeks
Arm/Group Title	Adapalene / BPO Gel
Arm/Group Description	Adapalene 0.3% / BPO 2.5% gel, once daily in the evening 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
All Cause Mortality
	Adapalene / BPO Gel
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	Adapalene / BPO Gel
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	Adapalene / BPO Gel
	Affected / at Risk (%)	# Events
Total	9/50 (18%)
General disorders
Pyrexia	2/50 (4%)	2
Nervous system disorders
Headache	3/50 (6%)	4
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change	2/50 (4%)	2
Pruritus	2/50 (4%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.