An interventional study of Test product and Comparator product in Acne, sponsored by Pierre Fabre Dermo Cosmetique. Recruiting at 1 site in Brazil. Open to participants aged 14 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Not applicable, Interventional, and Supportive care
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Criteria related to the disease:
Criteria related to treatments and/or products:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Test product
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.
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.
Assessment 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
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jul 2025, 12 months after the start.
Of 62 industry-sponsored interventional studies with no phase under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's planned 12 months is above that.
Counting every sponsor, half of 120 studies reached it within 9 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
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