Clinical trial NCT06716398: A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acne
Keywords: acne
face
young adults
teenagers
treatment phase
maintenance
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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

Primary outcomes:
measure: Assessment of number of total acne lesions on the face
timeFrame: Assessment after 24 weeks of use
Secondary outcomes:
measure: Investigator's global assessment (IGA)
timeFrame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Acne lesions counting
timeFrame: Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Acne QoL questionnaire
timeFrame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Subject's Global change Assessment (SGA)
timeFrame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Post-Inflammatory Hyperpigmentation (PIH) lesions counting
timeFrame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Post-Inflammatory Erythema (PIE) lesions counting
timeFrame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Subject's Global change Assessment (SGA) of post inflammatory lesions
timeFrame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Acne worsening/ relapse
timeFrame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Time to relapse
timeFrame: Assessment after 4 weeks and 12 weeks of use, without reference medical treatment
measure: Global tolerance assessed by the investigator on a 5-point scale
timeFrame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
measure: Compliance of the subjects to the product RV4133C
timeFrame: Through study completion, 6 months
measure: Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient
timeFrame: Assessed after 4 weeks of use
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UNIFESP
Study officials:
References: