An interventional study of Test product RV3278BB-OS0386 and Control product RV3278B-OS0548 in Acne, sponsored by Pierre Fabre Dermo Cosmetique. Active, not recruiting at 5 sites in 3 countries. Open to participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Pierre Fabre Dermo Cosmetique · Not applicable, Interventional, and Other
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 102 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non Inclusion criteria:
This group will apply the test cosmetic product
Other: Test product RV3278BB-OS0386
This group will apply the control cosmetic product
Other: Control product RV3278B-OS0548
Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study
Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study
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 )
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.
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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
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).
Skin potential hydrogen
Skin potential hydrogen measurement by pH meter.
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).
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Pierre Fabre Dermo Cosmetique