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

February 16, 2021 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany, 48159
        • EGBERT Mi-Ran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Benzaknen treatment regimen
Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)
Drug: Benzoyl Peroxide
Other: Dermotivin® Soft Liquid cleanser
Other: Cetaphil® Dermacontrol Moisturizer SPF30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Collaborators

Proinnovera GmbH

Investigators

  • Principal Investigator: Mi-Ran EGBERT, MD, Proinnovera GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.105041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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