NCT02716090

Clinical Trial Phase III to Assess the Non-inferiority of Dalap Duo® Product Compared to Epiduo® in the Treatment of Acne Vulgaris

National Clinical Trial, Phase III, Monocentric, Randomized, Open, Controlled, Parallel Study to Assess the Non-inferiority of Dalap Duo® Product (0,1% Adapalene and 2,5% Benzoyl Peroxide Gel Cream) Compared to Epiduo® (0,1% Adapalene and 2,5% Benzoyl Peroxide Gel) in the Treatment of Acne Vulgaris in Population of Men and Women

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the non-inferiority of the product Dalap Duo® compared to Epiduo® medicine to treat acne. Half of the participants will receive Dalap Duo®, while the other half will receive Epiduo®.

Detailed description

The investigational product produced by Aché that will be evaluated in this trial is a cream gel, comprising 0.1% of adapalene 2.5% and benzoyl peroxide. It's a topical cream gel that is stored on a laminated tube containing 30 grams. Of the 376 research participants with acne vulgaris participating in the study, 188 will be treated with the investigational product Cream Gel. The duration of the participants in the study will be up to one hundred twenty-four days, contemplating screening visit, randomization visit, four follow-up visits, a final visit and a phone contact 30 days after final visit. Of the one hundred twenty and fourth days of the study period, the participants will be treated for eighty four days. Regarding the control group, the active comparator is Epiduo®, manufactured by Galderma Laboratories, and its formulation is composed of 0.1% adapalene 2.5% and benzoyl peroxide. This is a topical gel stored in laminated tube with 30 grams. Of the 376 research participants with acne vulgaris that will participate in the study, 188 will be treated with the active comparator Epiduo®. The duration of the participants in the study will be up to one hundred twenty-four days, contemplating screening visit, randomization visit, four follow-up visits, a final visit and a phone contact 30 days after final visit. Of One hundred twenty and fourth days of the study period, the participants will be treated for eighty four days.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene and Benzoyl peroxide Dalap Duo®
DRUG	Adapalene and Benzoyl peroxide Epiduo®

Timeline

• Primary completion: 2015-11-01
• First posted: 2016-03-23
• Last updated: 2017-02-15