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 : December 30, 2019
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
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
|United States, Texas|
|Austin, Texas, United States, 78759|