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The aim of this study is to evaluate the efficacy of the RV3278B-OS0386 cosmetic product, compared to the control product in managing acne relapse during the 12-month maintenance phase follow-up after oral isotretinoin treatment in adult subjects with facial acne.
This study is conducted as a multicentric, randomized, blinded, comparative study in Europe.
A total number of 102 subjects included and randomized in 2 parallel groups:
Subjects will be followed at regular intervals for up to 12 months or until the relapse of their acne on the face, whichever occurs first.
6 visits are planned:
As part of an ancillary exploratory assessment, outcome measures will also be evaluated on augmented datasets including both study subject's data and synthetic data generated from the study subject's data by artificial intelligence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | This group will apply the test cosmetic product |
|
| Control Group | Placebo Comparator | This group will apply the control cosmetic product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product RV3278BB-OS0386 | Other | Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acne relapse rate | The acne relapse rate is defined as percentage of subjects experiencing acne relapse on the face according to the investigator | From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination ) |
| Measure | Description | Time Frame |
|---|---|---|
| Acne severity by investigator | Acne severity will be assessed by the investigator on the face using a 6-point scale (0 to 5 with 0: clear and 5: very severe) | Visit 1 (Day 1),Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination). |
| Time to acne relapse |
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Inclusion Criteria:
Non Inclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de santé Sabouraud | Paris | 75010 | France | |||
| Humanitas Research Hospital - Unita dermatologica |
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| Control product RV3278B-OS0548 | Other | Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study |
|
Time to acne relapse will be calculated from the date of the visit 1 until the date of the acne relapse as assessed by the investigator. |
| From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination) |
| Acne lesions count | Assessed by the investigator according to the Lucky Method by counting papules, pustules, open and closed comedones on the face | Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination). |
| Post-inflammatory lesions count | Assessed by the investigator by counting post-inflammatory hyperpigmentation and erythema lesions on the face | Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination). |
| Acne severity by subject | Acne severity will be assessed by the subject on the face using a 7-point scale (-3 to 3 with -3: much worse and 3: much improved) | Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination), and monthly at home. |
| Quality of life questionnaire | Quality of life will be assessed by the subject by completing the Cardiff Acne Disability Index Questionnaire consisting in 5 questions, each response is on a 4-point scale. | Visit 1 (Day 1), Visit 3 (Month 3) and Visit 6 (Month 12 or early termination). |
| Adverse events | Adverse events occurrence will be determined by the subject or 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 6 ( Month 12 or early termination) |
| Global Tolerance | Global Tolerance will be assessed by the investigator with 5-point scale (from 0: bad to 5: excellent) | Visit 3 (Month 3) and Visit 6 (Month 12 or early termination). |
| Acceptability Questionnaire assessment | Acceptability questionnaire regarding the use of the product will be completed by the subject. | Visit 4 (Month 6) and Visit 6 (Month 12 or early termination). |
| Standardized photographs of the subject's face for illustrative purpose only | for illustrative purpose only | Visit 1 (Day 1), Visit 4 (Month 6), and Visit 6 (Month 12 or early termination). |
| Transepidermal water loss | Transepidermal water loss measurement by Tewameter. | Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination). |
| Skin potential hydrogen | Skin potential hydrogen measurement by pH meter. | Visit 1 (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4 (Month 6), Visit 5 (Month 9) and Visit 6 (Month 12 or early termination). |
| Milan |
| 20089 |
| Italy |
| Istituto Dermopatico dell'Immacolata in Roma | Roma | 00167 | Italy |
| Dr. E.Karamon Private Practice | Malbork | Poland | 82200 | Poland |
| Dr. I.Karamon Private Practice | Gdansk | 80280 | Poland |
| 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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