Acne
Conditions
Keywords
acne, face, young adults, teenagers, treatment phase, maintenance
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.
Interventions
OTHERTest 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.
OTHERComparator 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.
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of number of total acne lesions on the face | Assessment after 24 weeks of use | Number of total acne lesions by counting according to the Lucky method performed by the investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acne lesions counting | Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | Number of all type of acne lesions by counting according to subject's photographs analysis using acne Artificial Intelligence |
| Acne QoL questionnaire | Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | Assessed by the subject via a specific questionnaire of 19 questions |
| Subject's Global change Assessment (SGA) | Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | Assessed by the subject via a 7-point scale: SGA of acne severity |
| Post-Inflammatory Hyperpigmentation (PIH) lesions counting | Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | Number of PIH lesions by counting according to the Lucky method performed by the investigator |
| Post-Inflammatory Erythema (PIE) lesions counting | Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | Number of PIE lesions by counting according to the Lucky method performed by the investigator |
| Investigator's global assessment (IGA) | Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | Assessed by the investigator on the face on a 5-point scale ranged from 0 (clear) to 4 (severe) |
| Acne worsening/ relapse | Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | 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 to relapse | Assessment after 4 weeks and 12 weeks of use, without reference medical treatment | 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). |
| Global tolerance assessed by the investigator on a 5-point scale | Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | — |
| Compliance of the subjects to the product RV4133C | Through study completion, 6 months | The subject will report his/her compliance in a subject's diary |
| Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient | Assessed after 4 weeks of use | 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). |
| Subject's Global change Assessment (SGA) of post inflammatory lesions | Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use | Assessed by the subject via a 7-point scale: SGA of post inflammatory lesions (PIH and PIE) |
Countries
Brazil
Contacts
Primary ContactAdeline Bacquey
Backup ContactChristophe Chamard
Outcome results
None listed