Actively Recruiting
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
Led by Pierre Fabre Dermo Cosmetique · Updated on 2024-12-04
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the overall benefit and tolerance of a cosmetic product called RV4133C - Formula JT2559 as complementary care alongside a topical medical treatment for facial acne. This study focuses on teenagers and young adults aged 14 to 24 with mild to moderate acne, comparing the tested product to a light moisturizing cream over two phases: a 3-month associated treatment phase plus a 3-month maintenance phase. Participants will apply either the tested cosmetic product or a comparator moisturizing cream twice daily to the entire face while using the prescribed topical medical treatment during the first 3 months. After this associated treatment phase, they will continue applying the product alone for an additional 3 months during the maintenance phase. The study is randomized and investigator-blinded, aiming to assess efficacy and tolerance throughout these 6 months. During the study, researchers will evaluate the number of total acne lesions after 24 weeks, along with multiple other measures including Investigator's Global Assessment, lesion counts at several timepoints, quality of life questionnaires, and assessments of post-inflammatory hyperpigmentation and erythema. Tolerance, patient satisfaction, compliance, and acne relapse will also be monitored. Participants can expect regular visits for assessments and questionnaires over the full 6-month study period.
CONDITIONS
Brief Title
A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female aged between 14 and 24 years (included)
- Facial acne with Investigator's Global Assessment (IGA) severity score of 2 or 3 on a 0 to 4 scale
- Prescription of 12 weeks of a reference topical medical treatment required from the day of inclusion for mild to moderate face acne
You will not qualify if you...
- Facial skin disease other than acne or dermatological conditions on the face that could affect study assessments
- Acne conglobata, acne fulminans, nodulocystic acne, or acneiform eruptions as assessed by the investigator
- Pigmentation disorders other than acne-related post-inflammatory hyperpigmentation that could interfere with assessments
- Use of topical or oral treatments established or modified recently or planned during the study that could affect efficacy or tolerance evaluation of the study products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants apply the cosmetic product twice daily in association with a reference medical treatment for facial acne.
Visits at baseline, 1 week, 4 weeks, and 12 weeks
Duration - 3 months
Participants apply the cosmetic product twice daily alone without the reference medical treatment.
Visits at 16 weeks and 24 weeks
Trial Site Locations
Total: 1 location
1
UNIFESP
São Paulo, Brazil, 04024-002
Actively Recruiting
Research Team
A
Adeline Bacquey
C
Christophe Chamard
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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