Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Benzoyl Peroxide; Other: Dermotivin® Soft Liquid cleanser; Other: Cetaphil® Dermacontrol Moisturizer SPF30

• Registration Number: NCT02589405
• Lead Sponsor: Galderma R&D

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2017-08-25
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-20
• Results First Posted: 2019-02-11
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Benzaknen treatment regimen	Dermotivin® Soft Liquid cleanser	Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)
Benzaknen treatment regimen	Cetaphil® Dermacontrol Moisturizer SPF30	Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)
Benzaknen treatment regimen	Benzoyl Peroxide	Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)

Primary Outcome Measures

Name	Time	Method
Number of Participants Satisfied and Very Satisfied With Regimen	12 weeks	Number of subjects satisfied and very satisfied with the three-part treatment regimen

Trial Locations

Locations (1)

EGBERT Mi-Ran; 🇩🇪 Münster, Germany