RecruitingNot ApplicableNCT06716398

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

A Randomized Investigator-blinded Comparative Study to Assess the Efficacy of the Cosmetic Care Product RV4133C - Formula JT2559 in Subjects With Facial Acne, During a 3-month-associated-treatment Phase Followed by a 3-month-maintenance Phase


Sponsor

Pierre Fabre Dermo Cosmetique

Enrollment

60 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 14 YearsMax Age: 24 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

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Interventions

OTHERTest product

Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.

OTHERComparator product

Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.


Locations(1)

UNIFESP

São Paulo, Brazil

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NCT06716398


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