AcneNCT06659861
Efficacy of Cosmetic Product RV3278B-OS0386 on Skin Surface Ecosystem, in Teenagers with Mild to Moderate Facial Acne
A study testing RV3278B-OS0386 and RV4632A-RY1845 in people with Acne, run by Pierre Fabre Dermo Cosmetique at 1 site in Romania.
Trial summary
The aim of this exploratory study is to better understand the mechanisms of action of the RV3278B-OS0386 cosmetic product on the cutaneous ecosystem, in acne context. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Acne
- What is being tested?
- RV3278B-OS0386 and RV4632A-RY1845
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteRomania
- Study dates
- 10 Oct 2024to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Criteria related to the population:
- Female and male aged between 12 and 17 years included
- Subject having signed his/her written informed consent/assent for his/her participation in the study
- Subject whose parent(s) or guardian(s) has (have) given his/her (their) written consent for their child's participation in the study
- Subject affiliated to a social security system or health insurance, or is a beneficiary
- Subject whose parent(s) or guardian(s) is (are) registered with health social security or health insurance
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- Subject and/or parents certifying the truth of the personal information declared to the investigator
- Cooperative subject and/or parent(s)/legal representative(s), aware of the necessity and duration of controls so that perfect adhesion to the protocol established by the clinical trial centre could be expected
- Subject with phototype I, II, III, IV according to the Fitzpatrick scale
- For woman/girl of childbearing potential:
- use of an effective method of contraception, as assessed by the investigator, introduced and unchanged for at least 1 month (3 months in case of hormonal contraception) before inclusion in the study
- accept to go on using it during the whole duration of the study
- Criteria related to the skin condition (acne):
- Subject with combination, combination to greasy skin tendency or oily skin on face
- Subject with mild to moderate acne vulgaris on face; GEA from 2 to 3
- Subject with predominantly non-inflammatory acne on the forehead
- Subject with at least 20 open comedones on the face, excluding the nose area, at the inclusion
- Subject presenting on his/her forehead (extension possible to the temples, but excluding the hair): target areas suitable for study samplings and measurements:
- Subject having a sensitive skin, according to his/her own self-assessment
- Criteria related to the treatments and/or products:
- Subject who used the same facial cleansing product, shaving products, make-up (if applicable) for at least 1 month before inclusion and is willing to keep it during the whole duration of the study
- Non Inclusion Criteria:
- Criteria related to the population:
- Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in writing in his/her diary
- Subject whose parent(s) or guardian(s) is(are) unable to understand the information given (for linguistic or psychiatric reasons) and to give his/her consent in writing
- For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
- Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship
- Subject whose parent(s) or guardian(s) who has forfeited his/her freedom by administrative or legal decision or under guardianship
- Subject or parent(s)/legal representative(s) not able to be contacted in case of emergency
- Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
- Subject whose parent(s) or guardian(s) is(are) unable to comply with study-related constraints
- Subject admitted in a sanitary or social facility
- Subject planning an hospitalization during the study
- Subject who is currently participating, who plans to participate or who has participated within the previous weeks or months in another clinical study liable to interfere with the study assessments according to the investigator's assessment
- Subject is in a position likely to represent a conflict of interest and/or is a family member of any people involved in the conduct of the study (secretary, nurse, technician,…), of the investigational site
- Criteria related to the subject's health / skin condition:
- Subject with history of allergy or intolerance to any of the study products ingredients
- Subject with history of allergy or intolerance to any material used for the research (like pen, pencil, marker pen, sticking plaster…)
- Subject having any other dermatologic condition than acne, or characteristics (like tattoo) on the study area(s) liable to interfere with the study assessments
- Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Presence of more than an acne inflammatory nodule in the whole face
- Clinical signs of hormone dysfunction or hyperandrogenism
- Severe form of acne (acne conglobate, acne fulminans or nodulocystic acne) or acneiform eruptions, in the investigator's opinion
- Exposure to UV-Rays or excessive exposure to sunlight within the previous month
- Criteria related to treatments and/or products:
- Any surgery, chemical (e.g.: skin peel) or physical treatment on the face in the 12 months before the inclusion visit or planned during the study
- Systemic isotretinoin treatment taken in 6 months before the inclusion or planned during the study
- Systemic acne treatment (e.g., zinc gluconate, antibiotics, hormonal treatment [excluding contraception] …] taken in the 3 months before the inclusion or planned to be taken during the study
- Probiotics taken orally in the month before the inclusion or planned to be taken during the study
- Use of self-tanning product on the face in the month before the inclusion or planned to be used during the study
- Topical acne treatment (e.g., benzoyl peroxide, vitamin A and its derivates) applied on the face in the month before the inclusion or planned during the study
- Topical or systemic Non-Steroidal Anti-Inflammatory (NSAI), corticosteroids, taken or applied to the face in the 2 weeks before the inclusion or planned to be taken/applied during the study
- Change in subject's usual make-up, facial hygiene habits, cleansing products, care products, shaving products and/or use new products on the face in the 2 weeks before the inclusion visit or planned during the study
- Skincare product for acne (e.g., product containing any ingredient, like "anti-blemish" active ingredient, liable to interfere with the study according to investigator's assessment) applied to the face in the 2 weeks before the inclusion visit or planned to be applied during the study
- Home care on the face (including exfoliation, masks, home peels, etc.) used in the 2 weeks before the inclusion visit or planned to be used during the study
- Any topical or systemic treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the assessments performed during the study according to the investigator's opinion
- Last face shaving performed in the 2 days before the inclusion visit
- Any topical treatment or product (including make-up) applied to the face between the last wash (performed the day before the visit) and the inclusion visit
- Water applied on the face within 8 hours before the inclusion
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Randomized Comparative Study to Evaluate the Effect of RV3278B-OS0386 on Skin Ecosystem, in Teenagers with Mild to Moderate Facial Acne
The aim of this exploratory study is to better understand the mechanisms of action of the RV3278B-OS0386 cosmetic product on the cutaneous ecosystem, in acne context.
Read the detailed description
This study will be conducted as an exploratory monocentric, randomized, comparative study.
A total number of 52 subjects (teenagers with mild to moderate facial acne) will be included and randomized in two parallel groups :
- The tested group who will apply the tested product RV3278B-OS0386
- The control group who will not apply the tested product. However, they will receive the associated product (RV4632A-RY1845), to be applied in the event of facial skin discomfort only. 3 visits are planned:
- Visit 1 (Day 1) : Inclusion, randomization, collection of biological samples on the forehead and start of product application.
- Visit 2 (Day 29 +/- 3 days) : Phone call follow-up
- Visit 3 (Day 57, a window of + 3 days is allowed): End-of-study visit - Collection of biological samples on the forehead.
- Conditions
- Acne
- Being tested
- RV3278B-OS0386, RV4632A-RY1845
- Keywords
- Skin ecosystem, cosmetic care product
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV3278B-OS0386Other
Cosmetic product to be applied twice a day on the face during the whole study
RV4632A-RY1845Other
Cosmetic product to be applied in the event of facial skin discomfort only
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | This group will apply the RV3278B-OS0386 cosmetic product for acne prone skin. Receives: Other: RV3278B-OS0386 |
| Control Group | Other | This group will receive the associated cosmetic product RV4632A-RY1845 (emollient cream), to be applied in the event of facial skin discomfort only. Receives: Other: RV4632A-RY1845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the RV3278B on acne severity
Assessed by the investigator on a 6-point scale (0 to 5 with 0: clear and 5: very severe)
Measured: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Effect of the RV3278B on open comedones.
Quantification of open comedones
Measured: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Effect of the RV3278B on biological criteria within isolated comedones
Analyses of comedone composition
Measured: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Effect of the RV3278B on biological criteria from the skin surface
Analyses of skin microbiota
Measured: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Effect of the RV3278B on biometrological criteria
Skin potential hydrogen measurement by pH meter
Measured: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Adverse events related to RV3278B
Adverse events occurrence will be determined by the 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 3 (Day 57)
Secondary outcomes (1)
Illustrative Outcome : Standardized photographs of the subject's face
Measured: Visit 1 (Day 1) to Visit 3 (Day 57).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start10 Oct 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
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
- None (open label)
- Enrolment
- 52 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
- NCT06659861
- Sponsor's protocol ID
- RV3278B20240316
- Status last verified
- Mar 2025
- First submitted
- 21 Oct 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized Comparative Study to Evaluate the Effect of RV3278B-OS0386 on Skin Ecosystem, in Teenagers with Mild to Moderate Facial Acne
- ClinicalTrials.gov ID
- NCT06659861
- Acronym / sponsor ID
- RV3278B20240316
- Conditions
- Acne
- Keywords
- Skin ecosystem, cosmetic care product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 26 Oct 2024 (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 exploratory study is to better understand the mechanisms of action of the RV3278B-OS0386 cosmetic product on the cutaneous ecosystem, in acne context.
Detailed description
This study will be conducted as an exploratory monocentric, randomized, comparative study.
A total number of 52 subjects (teenagers with mild to moderate facial acne) will be included and randomized in two parallel groups :
- The tested group who will apply the tested product RV3278B-OS0386
- The control group who will not apply the tested product. However, they will receive the associated product (RV4632A-RY1845), to be applied in the event of facial skin discomfort only. 3 visits are planned:
- Visit 1 (Day 1) : Inclusion, randomization, collection of biological samples on the forehead and start of product application.
- Visit 2 (Day 29 +/- 3 days) : Phone call follow-up
- Visit 3 (Day 57, a window of + 3 days is allowed): End-of-study visit - Collection of biological samples on the forehead.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: RV3278B-OS0386This group will apply the RV3278B-OS0386 cosmetic product for acne prone skin. |
| Control Group | Other | Other: RV4632A-RY1845This group will receive the associated cosmetic product RV4632A-RY1845 (emollient cream), to be applied in the event of facial skin discomfort only. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (59 listed)
- Female and male aged between 12 and 17 years included
- Subject having signed his/her written informed consent/assent for his/her participation in the study
- Subject whose parent(s) or guardian(s) has (have) given his/her (their) written consent for their child's participation in the study
- Subject affiliated to a social security system or health insurance, or is a beneficiary
- Subject whose parent(s) or guardian(s) is (are) registered with health social security or health insurance
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 |
|---|---|---|
| RV3278B-OS0386Cosmetic product to be applied twice a day on the face during the whole study | Other | Test Group |
| RV4632A-RY1845Cosmetic product to be applied in the event of facial skin discomfort only | Other | Control Group |
Primary outcome
Effect of the RV3278B on acne severity
Time frame: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Assessed by the investigator on a 6-point scale (0 to 5 with 0: clear and 5: very severe)
Effect of the RV3278B on open comedones.
Time frame: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Quantification of open comedones
Effect of the RV3278B on biological criteria within isolated comedones
Time frame: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Analyses of comedone composition
Effect of the RV3278B on biological criteria from the skin surface
Time frame: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Analyses of skin microbiota
Effect of the RV3278B on biometrological criteria
Time frame: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
Skin potential hydrogen measurement by pH meter
Adverse events related to RV3278B
Time frame: From Visit 1 (Day 1) to Visit 3 (Day 57)
Adverse events occurrence will be determined by the subject's/parent(s) or guardian(s) spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
1 secondary outcome
Illustrative Outcome : Standardized photographs of the subject's face
Time frame: Visit 1 (Day 1) to Visit 3 (Day 57).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV3278B-OS0386 and RV4632A-RY1845 in people with Acne, run by Pierre Fabre Dermo Cosmetique at 1 site in Romania.
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 59 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: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of the RV3278B on acne severity (time frame: Change from Visit 1 (Day 1) to Visit 3 (Day 57).). The study lists 6 primary outcomes in all. 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 17 Mar 2025.