Acne
Conditions
Keywords
Acne
Brief summary
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.
Detailed description
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: * Test group: twice daily application of the RV3278B-OS0386 cosmetic product on the whole face * Control group: twice daily application of the RV3278B-OS0548 cosmetic product on the whole face 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: * Visit 1 (Day 1): Inclusion, Randomization and start of product * Visit 2 (month 1) * Visit 3 (month 3) * Visit 4 (month 6) * Visit 5 (month 9) * Visit 6 (month 12): End of study Visit In case of subject's acne relapse confirmed by the investigator, subject will be withdrawn from the study. 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.
Interventions
OTHERTest product RV3278BB-OS0386
Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study
OTHERControl product RV3278B-OS0548
Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female aged between 15 and 35 years included * Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable * Subject who recently completed his/her first course of oral isotretinoin treatment * Subject with clear or almost clear facial acne Non Inclusion criteria: * Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements * Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments * Severe or complicated cases of acne (ex: acne conglobate) according to investigator's assessment * Any acute, chronic or progressive disease or medical history liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements * Any surgery, chemical (e.g.: skin peel) or physical treatment on the face done within 12 months before the inclusion or planned during the study * Topical or systemic product or 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 product according to the investigator's assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acne relapse rate | From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination ) | The acne relapse rate is defined as percentage of subjects experiencing acne relapse on the face according to the investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to acne relapse | From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination) | 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. |
| Acne lesions count | 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). | Assessed by the investigator according to the Lucky Method by counting papules, pustules, open and closed comedones on the face |
| Post-inflammatory lesions count | 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). | Assessed by the investigator by counting post-inflammatory hyperpigmentation and erythema lesions on the face |
| Acne severity by subject | 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. | 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) |
| Quality of life questionnaire | Visit 1 (Day 1), Visit 3 (Month 3) and Visit 6 (Month 12 or early termination). | 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. |
| Acne severity by investigator | 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 will be assessed by the investigator on the face using a 6-point scale (0 to 5 with 0: clear and 5: very severe) |
| Global Tolerance | Visit 3 (Month 3) and Visit 6 (Month 12 or early termination). | Global Tolerance will be assessed by the investigator with 5-point scale (from 0: bad to 5: excellent) |
| Acceptability Questionnaire assessment | Visit 4 (Month 6) and Visit 6 (Month 12 or early termination). | Acceptability questionnaire regarding the use of the product will be completed by the subject. |
| Standardized photographs of the subject's face for illustrative purpose only | Visit 1 (Day 1), Visit 4 (Month 6), and Visit 6 (Month 12 or early termination). | for illustrative purpose only |
| Transepidermal water loss | 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). | Transepidermal water loss measurement by Tewameter. |
| Skin potential hydrogen | 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 measurement by pH meter. |
| Adverse events | From Visit 1 (Day 1) to Visit 6 ( Month 12 or early termination) | 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 |
Countries
France, Italy, Poland
Outcome results
None listed