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The aim of this exploratory study is to better understand the mechanisms of action of the RV3278B-OS0386 cosmetic product on the cutaneous ecosystem, in acne context.
This study will be conducted as an exploratory monocentric, randomized, comparative study.
A total number of 52 subjects (teenagers with mild to moderate facial acne) will be included and randomized in two parallel groups :
The tested group who will apply the tested product RV3278B-OS0386
The control group who will not apply the tested product. However, they will receive the associated product (RV4632A-RY1845), to be applied in the event of facial skin discomfort only.
3 visits are planned:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | This group will apply the RV3278B-OS0386 cosmetic product for acne prone skin. |
|
| Control Group | Other | This group will receive the associated cosmetic product RV4632A-RY1845 (emollient cream), to be applied in the event of facial skin discomfort only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV3278B-OS0386 | Other | Cosmetic product to be applied twice a day on the face during the whole study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the RV3278B on acne severity | Assessed by the investigator on a 6-point scale (0 to 5 with 0: clear and 5: very severe) | Change from Visit 1 (Day 1) to Visit 3 (Day 57). |
| Effect of the RV3278B on open comedones. | Quantification of open comedones | Change from Visit 1 (Day 1) to Visit 3 (Day 57). |
| Effect of the RV3278B on biological criteria within isolated comedones | Analyses of comedone composition | Change from Visit 1 (Day 1) to Visit 3 (Day 57). |
| Effect of the RV3278B on biological criteria from the skin surface | Analyses of skin microbiota | Change from Visit 1 (Day 1) to Visit 3 (Day 57). |
| Effect of the RV3278B on biometrological criteria | Skin potential hydrogen measurement by pH meter | Change from Visit 1 (Day 1) to Visit 3 (Day 57). |
| Adverse events related to RV3278B | Adverse events occurrence will be determined by the subject's/parent(s) or guardian(s) spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation | From Visit 1 (Day 1) to Visit 3 (Day 57) |
| Measure | Description | Time Frame |
|---|---|---|
| Illustrative Outcome : Standardized photographs of the subject's face | Visit 1 (Day 1) to Visit 3 (Day 57). |
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Inclusion Criteria:
Criteria related to the population:
Female and male aged between 12 and 17 years included
Subject having signed his/her written informed consent/assent for his/her participation in the study
Subject whose parent(s) or guardian(s) has (have) given his/her (their) written consent for their child's participation in the study
Subject affiliated to a social security system or health insurance, or is a beneficiary
Subject whose parent(s) or guardian(s) is (are) registered with health social security or health insurance
Subject and/or parents certifying the truth of the personal information declared to the investigator
Cooperative subject and/or parent(s)/legal representative(s), aware of the necessity and duration of controls so that perfect adhesion to the protocol established by the clinical trial centre could be expected
Subject with phototype I, II, III, IV according to the Fitzpatrick scale
For woman/girl of childbearing potential:
Criteria related to the skin condition (acne):
Subject presenting on his/her forehead (extension possible to the temples, but excluding the hair): target areas suitable for study samplings and measurements:
Inclusion criteria required for at least 26 subjects:
• Subject having a sensitive skin, according to his/her own self-assessment
Criteria related to the treatments and/or products:
• Subject who used the same facial cleansing product, shaving products, make-up (if applicable) for at least 1 month before inclusion and is willing to keep it during the whole duration of the study
Non Inclusion Criteria:
Criteria related to the population:
Criteria related to the subject's health / skin condition:
Criteria related to treatments and/or products:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cidp Romania | Bucharest | 011607 | Romania |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| RV4632A-RY1845 | Other | Cosmetic product to be applied in the event of facial skin discomfort only |
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