Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.

N/AActive Not RecruitingNCT07341659

Pierre Fabre Dermo Cosmetique102 enrolled

Overview

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: * 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Visit 6 (month 12): End of study Visit In case of subject's acne relapse confirmed by the investigator, subject will be withdrawn from the study.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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

102

Conditions

Acne

Interventions

Test product RV3278BB-OS0386OTHER

Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study

Control product RV3278B-OS0548OTHER

Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study

Eligibility

Sex: ALLMin age: 15 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (5)

Centre de santé Sabouraud

Paris, France

Humanitas Research Hospital - Unita dermatologica

Milan, Italy

Istituto Dermopatico dell'Immacolata in Roma

Roma, Italy

Dr. E.Karamon Private Practice

Malbork, Poland, Poland

Outcomes

Primary Outcomes

Acne relapse rate

The acne relapse rate is defined as percentage of subjects experiencing acne relapse on the face according to the investigator

Time frame: From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination )

Secondary Outcomes

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)

Time frame: 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

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.

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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