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Completed

NCT Number: NCT02589405

Benzac 5% Gel in Combination With Cosmetic Products in 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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

EGBERT Mi-Ran

Münster, 48159, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Benzoyl peroxide

Drug

Dermotivin® Soft Liquid cleanser

Other

Cetaphil® Dermacontrol Moisturizer SPF30

Other

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Collaborators

  • Proinnovera GmbH

Registry information

Official study 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

Acronym: Benzac

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2015
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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