Benzaknen® 5% Gel in Combination With Dermotivin® Soft Liquid Soap and Non-comedogenic Cetaphil® Dermacontrol Moisturizer SPF30 in the Treatment of Mild-to-moderate Acne Vulgaris
Overview
- Phase
- Phase 4
- Intervention
- Benzoyl Peroxide
- Conditions
- Acne Vulgaris
- Sponsor
- Galderma R&D
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Participants Satisfied and Very Satisfied With Regimen
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The aim of this study is to evaluate a complete acne regimen consisting of a medication (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil® Dermacontrol Moisturizer SPF30 in patients with acne.
Detailed Description
The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with 2 cosmetic products including a foam soap, Dermotivin® Soft Liquid soap, and a non comedogenic moisturizer, Cetaphil® Dermacontrol Moisturizer SPF30, in patients with mild to moderate acne, after 12 weeks of treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subject of any ethnic background of 12 years or older.
- •Subject with mild or moderate facial acne vulgaris defined as an Investigator Global Assessment (IGA) score at 2 or 3 on a 0-4 scale.
- •Subject with any skin phototype according to T.B. Fitzpatrick skin phototype definitions.
Exclusion Criteria
- •Subject with severe acne (IGA\>3) with nodules, cysts, scars or extra-facial lesions,
- •Female subject who is pregnant, lactating or planning a pregnancy during the study,
- •Subject susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face,
Arms & Interventions
Benzaknen treatment regimen
Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)
Intervention: Benzoyl Peroxide
Benzaknen treatment regimen
Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)
Intervention: Dermotivin® Soft Liquid cleanser
Benzaknen treatment regimen
Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)
Intervention: Cetaphil® Dermacontrol Moisturizer SPF30
Outcomes
Primary Outcomes
Number of Participants Satisfied and Very Satisfied With Regimen
Time Frame: 12 weeks
Number of subjects satisfied and very satisfied with the three-part treatment regimen