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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
60
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.
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.
UNIFESP
São Paulo, Brazil
RECRUITINGAssessment of number of total acne lesions on the face
Number of total acne lesions by counting according to the Lucky method performed by the investigator
Time frame: Assessment after 24 weeks of use
Investigator's global assessment (IGA)
Assessed by the investigator on the face on a 5-point scale ranged from 0 (clear) to 4 (severe)
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne lesions counting
Number of all type of acne lesions by counting according to subject's photographs analysis using acne Artificial Intelligence
Time frame: Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne QoL questionnaire
Assessed by the subject via a specific questionnaire of 19 questions
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Subject's Global change Assessment (SGA)
Assessed by the subject via a 7-point scale: SGA of acne severity
Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Post-Inflammatory Hyperpigmentation (PIH) lesions counting
Number of PIH lesions by counting according to the Lucky method performed by the investigator
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Post-Inflammatory Erythema (PIE) lesions counting
Number of PIE lesions by counting according to the Lucky method performed by the investigator
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
Assessed by the subject via a 7-point scale: SGA of post inflammatory lesions (PIH and PIE)
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne worsening/ relapse
Number and percentage of acne worsening/ relapse, defined by the investigator by the necessity to change the topical medical treatment and/ or to introduce an oral medical treatment for facial acne
Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Time to relapse
The time to first acne relapse will be calculated from the date of Visit 3 (start of maintenance phase) to the date of failure (acne 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
The subject will report his/her compliance in a subject's diary
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
A questionnaire with a scale from 0 to 10 responding to statements about the effect of the product (0=not at all agree, 10=completely agree).
Time frame: Assessed after 4 weeks of use
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