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NCT02589405 Clinical Trial

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

Acne Vulgaris Clinical Trial

— Benzac  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02589405
Other study ID # RD.03.SPR.105041
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2015
Est. completion date January 2016

Study information
Verified date September 2018
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Benzoyl Peroxide

Other:
• Dermotivin® Soft Liquid cleanser

• Cetaphil® Dermacontrol Moisturizer SPF30

Locations
Country Name City State
Germany EGBERT Mi-Ran Münster

Sponsors (2)
Lead Sponsor Collaborator
Galderma R&D Proinnovera GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Satisfied and Very Satisfied With Regimen Number of subjects satisfied and very satisfied with the three-part treatment regimen 12 weeks
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