Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental |
| |
| Comparative group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessment after 24 weeks of use |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's global assessment (IGA) | Assessed by the investigator on the face on a 5-point scale ranged from 0 (clear) to 4 (severe) | Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use |
| Acne lesions counting |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Criteria related to the disease:
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeline Bacquey | Contact | +33562877753 | adeline.bacquey@pierre-fabre.com | |
| Christophe Chamard | Contact | +33562488566 | christophe.chamard@pierre-fabre.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIFESP | Recruiting | São Paulo | 04024-002 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D019066 | Facies |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator product | Other | 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. |
|
Number of all type of acne lesions by counting according to subject's photographs analysis using acne Artificial Intelligence
| 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 | 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 | 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 | 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 | 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) | 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 | 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). | Assessment after 4 weeks and 12 weeks of use, without reference medical treatment |
| 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 | The subject will report his/her compliance in a subject's diary | 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). | Assessed after 4 weeks of use |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |