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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Benzoyl Peroxide

Dermotivin® Soft Liquid cleanser

Cetaphil® Dermacontrol Moisturizer SPF30

About this trial

This is an interventional other trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

EGBERT Mi-Ran

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Benzaknen treatment regimen

Arm Description

Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)

Outcomes

Primary Outcome Measures

Number of Participants Satisfied and Very Satisfied With Regimen

Number of subjects satisfied and very satisfied with the three-part treatment regimen

Secondary Outcome Measures

Full Information

NCT ID

NCT02589405

First Posted

October 23, 2015

Last Updated

February 16, 2021

Sponsor

Galderma R&D

Collaborators

Proinnovera GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02589405

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

Collaborators

Proinnovera GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Benzaknen treatment regimen

Arm Type

Experimental

Arm Description

Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)

Intervention Type

Drug

Intervention Name(s)

Benzoyl Peroxide

Intervention Type

Other

Intervention Name(s)

Dermotivin® Soft Liquid cleanser

Intervention Type

Other

Intervention Name(s)

Cetaphil® Dermacontrol Moisturizer SPF30

Primary Outcome Measure Information:

Title

Number of Participants Satisfied and Very Satisfied With Regimen

Description

Number of subjects satisfied and very satisfied with the three-part treatment regimen

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mi-Ran EGBERT, MD

Organizational Affiliation

Proinnovera GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

EGBERT Mi-Ran

City

Münster

ZIP/Postal Code

48159

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

28678647

Citation

Kim MR, Kerrouche N. Combination of benzoyl peroxide 5% gel with liquid cleanser and moisturizer SPF 30 in acne treatment results in high levels of subject satisfaction, good adherence and favorable tolerability. J Dermatolog Treat. 2018 Feb;29(1):49-54. doi: 10.1080/09546634.2017.1342758. Epub 2017 Jul 5.

Results Reference

derived

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

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