AcneNCT07341659
Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.
A study testing Test product RV3278BB-OS0386 in people with Acne, run by Pierre Fabre Dermo Cosmetique at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Acne
- What is being tested?
- Test product RV3278BB-OS0386
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 28 Feb 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy2 sites
Humanitas Research Hospital - Unita dermatologica
Milan, 20089
Istituto Dermopatico dell'Immacolata in Roma
Roma, 00167
Poland2 sites
Dr. I.Karamon Private Practice
Gdansk, 80280
Dr. E.Karamon Private Practice
Malbork, Poland, 82200
About this study
Official title: A Multicentric, Randomized, Blinded, Comparative Study to Evaluate the Efficacy of the Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adult Subjects With Facial Acne.
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.
Read the 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.
- Conditions
- Acne
- Being tested
- Test product RV3278BB-OS0386, Control product RV3278B-OS0548
- Keywords
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | This group will apply the test cosmetic product Receives: Other: Test product RV3278BB-OS0386 |
| Control Group | Placebo comparator | This group will apply the control cosmetic product Receives: Other: Control product RV3278B-OS0548 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne relapse rate
The acne relapse rate is defined as percentage of subjects experiencing acne relapse on the face according to the investigator
Measured: From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination )
Secondary outcomes (12)
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start28 Feb 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341659
- Sponsor's protocol ID
- RV3278B20240495
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Randomized, Blinded, Comparative Study to Evaluate the Efficacy of the Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adult Subjects With Facial Acne.
- ClinicalTrials.gov ID
- NCT07341659
- Acronym / sponsor ID
- RV3278B20240495
- Conditions
- Acne
- Keywords
- Acne
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Test product RV3278BB-OS0386This group will apply the test cosmetic product |
| Control Group | Placebo comparator | Other: Control product RV3278B-OS0548This group will apply the control cosmetic product |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
- Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test product RV3278BB-OS0386Cosmetic product RV3278BB-OS0386 to be applied twice a day on the face during the whole study | Other | Test Group |
| Control product RV3278B-OS0548Cosmetic product RV3278B-OS0548 to be applied twice a day on the face during the whole study | Other | Control Group |
Primary outcome
Acne relapse rate
Time frame: 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
12 secondary outcomes
Acne severity by investigator
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 frame: From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination)
Acne lesions count
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
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
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
Time frame: Visit 1 (Day 1), Visit 3 (Month 3) and Visit 6 (Month 12 or early termination).
Adverse events
Time frame: From Visit 1 (Day 1) to Visit 6 ( Month 12 or early termination)
Global Tolerance
Time frame: Visit 3 (Month 3) and Visit 6 (Month 12 or early termination).
Acceptability Questionnaire assessment
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
Time frame: Visit 1 (Day 1), Visit 4 (Month 6), and Visit 6 (Month 12 or early termination).
Transepidermal water loss
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product RV3278BB-OS0386 in people with Acne, run by Pierre Fabre Dermo Cosmetique at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Poland, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acne relapse rate (time frame: From Visit 1 (Day 1) to Visit 6 (Month 12 or early termination )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.