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A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase

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Pierre Fabre

Status

Enrolling

Conditions

Acne

Treatments

Other: Comparator product
Other: Test product

Study type

Interventional

Funder types

Industry

Identifiers

NCT06716398
RV4133C20230380

Details and patient eligibility

About

In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. We also want to evaluate the tolerance of the tested product in association and in maintenance of the topical medical treatment.

Enrollment

60 estimated patients

Sex

All

Ages

14 to 24 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or Female aged between 14 and 24 years (included)
  • Subject with facial acne with score index severity IGA = 2 or 3, assessed on a scale ranged from 0 to 4.
  • Subject for whom a prescription of 12 weeks of a reference topical medical treatment is required from the day of the inclusion visit, for mild to moderate face acne

Exclusion criteria

Criteria related to the disease:

  • Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
  • Acne conglobata, Acne fulminans, nodulocystic acne or acneiform eruptions, according to investigator's assessment
  • Other type of pigmentation disorder than acne-related PIH liable to interfere with the study assessments according to the investigator

Criteria related to treatments and/or products:

  • Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Test Group
Experimental group
Treatment:
Other: Test product
Comparative group
Placebo Comparator group
Treatment:
Other: Comparator product

Trial contacts and locations

1

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Central trial contact

Christophe Chamard; Adeline Bacquey

Data sourced from clinicaltrials.gov

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