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

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Galderma

Status and phase

Completed
Phase 4

Conditions

Acne Vulgaris

Treatments

Other: Cetaphil® Dermacontrol Moisturizer SPF30
Other: Dermotivin® Soft Liquid cleanser
Drug: Benzoyl Peroxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02589405
RD.03.SPR.105041

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

12+ years old

Volunteers

No 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,

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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