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

NCT ID: NCT02589405

Last Updated: 2021-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Benzaknen treatment regimen

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

Group Type EXPERIMENTAL

Benzoyl Peroxide

Intervention Type DRUG

Dermotivin® Soft Liquid cleanser

Intervention Type OTHER

Cetaphil® Dermacontrol Moisturizer SPF30

Intervention Type OTHER

Interventions

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Benzoyl Peroxide

Intervention Type DRUG

Dermotivin® Soft Liquid cleanser

Intervention Type OTHER

Cetaphil® Dermacontrol Moisturizer SPF30

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Proinnovera GmbH

INDUSTRY

Sponsor Role collaborator

Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mi-Ran EGBERT, MD

Role: PRINCIPAL_INVESTIGATOR

Proinnovera GmbH

Locations

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EGBERT Mi-Ran

Münster, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 28678647 (View on PubMed)

Other Identifiers

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RD.03.SPR.105041

Identifier Type: -

Identifier Source: org_study_id

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