A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Test product, Comparator product.
- Who it may be relevant to
- Registry conditions: Acne. Basic parameters: 14 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Test 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. - Other Comparator 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.
Primary outcome measures
- Assessment of number of total acne lesions on the face [Time frame: Assessment after 24 weeks of use]
Secondary outcome measures (12)
- Investigator's global assessment (IGA) [Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Acne lesions counting [Time frame: Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Acne QoL questionnaire [Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Subject's Global change Assessment (SGA) [Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Post-Inflammatory Hyperpigmentation (PIH) lesions counting [Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Post-Inflammatory Erythema (PIE) lesions counting [Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Subject's Global change Assessment (SGA) of post inflammatory lesions [Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Acne worsening/ relapse [Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Time to relapse [Time frame: Assessment after 4 weeks and 12 weeks of use, without reference medical treatment]
- Global tolerance assessed by the investigator on a 5-point scale [Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
- Compliance of the subjects to the product RV4133C [Time frame: Through study completion, 6 months]
- Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient [Time frame: Assessed after 4 weeks of use]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Brazil · 1 center
- UNIFESP — São Paulo
Identifiers
NCT: NCT06716398 · RV4133C20230380