AcneNCT05640388
Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects
An observational study of Acne, run by Pierre Fabre Dermo Cosmetique at 2 sites in France.
Trial summary
The aim of the study is to understand the structural and functional modifications of the host, the microorganisms, and their interactions (host/microorganism relationship) before and after the RV3278A - ET0943 product application Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Acne
- What is being tested?
- RV3278A - ET0943 cosmetic product and RV4632A - RY1845 cosmetic product
- How many people
- 41 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Sep 2021to 12 Jan 2022
- Phase
- Observational
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects are enrolled during their usual medical care and/or from the database of the investigational sites. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the study.
Who may be able to join
- Related to the population:
- Subject aged between 12 to 25 years included
- Related to diseases:
- Subject having acne lesions on the face, with GEA (Global Acne Evaluation) score on the face is assessed as 2 (mild) or as 3 (moderate), on a scale ranged from 0 (clear- no lesion) to 5 (very severe)
- Subject having at least 20 open-comedones of about 1 mm in diameter on the face and possibly extractable
- Subject having a predominance of non-inflammatory acne lesions
Who cannot join
- Related to diseases:
- Subject having comedones only on the nose wings
- Subject with any other dermatological disease than acne or skin characteristics (like scar, tatoo) on the face liable to interfere with the study according to the investigator's assessment
- Subject with an acute or chronic 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
- Severe form of acne (Acne conglobata, Acne fulminans or nodulokystic acne) or acneiform induced rashes according to the investigator's assessment
- Clinical signs of a hormonal dysfunction or of a hyperandrogenism
Show all 9Show fewer
- Solar erythema on the face due to excessive UV exposur
- Related to the treatments/products:
- Any previous/concomitant treatment or product considered by the Investigator liable to interfere with the study data or incompatible with the study requirements or hazardous for the subject
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de santé SABOURAUD C.E.P.C
Paris
Centre de Recherche sur la Peau
Toulouse, 31400
About this study
Official title: An Exploratory, Comparative and Multicentric Study, to Evaluate the Effect of the RV3278A - ET0943 on the Host/Micro-organism Relationships in Acneic Subjects
The aim of the study is to understand the structural and functional modifications of the host, the microorganisms, and their interactions (host/microorganism relationship) before and after the RV3278A - ET0943 product application
- Conditions
- Acne
- Being tested
- RV3278A - ET0943 cosmetic product, RV4632A - RY1845 cosmetic product
- Keywords
- Comedones, Lipids, Blackheads, Host/Microorganism Relationship, Micro comedones
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV3278A - ET0943 cosmetic productOther
RV3278A - ET0943 study product is applied twice a day on the face during the whole study.
RV4632A - RY1845 cosmetic productOther
RV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort
| Study group | Role | What they receive |
|---|---|---|
| RV3278A arm : Treated group | This group will receive the RV3278A - ET0943 product Receives: Other: RV3278A - ET0943 cosmetic product | |
| RV4632A arm : Control group | This group will receive the RV4632A - RY1845 product Receives: Other: RV4632A - RY1845 cosmetic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the RV3278A on acne severity
Global Evaluation Acne (GEA), on a 6-point scale 0: Clear. No lesions
- Almost clear, Almost no lesions
- Mild
- Moderate
- Severe
- Very severe
Measured: Change from baseline to 2 months
Effect of the RV3278A on inflammatory and retentionnal lesions
Quantification of inflammatory and retentionnal lesions from image analysis
Measured: Change from baseline to 2 months
Effect of the RV3278A on microorganisms
Quantitative analysis by ddPCR (droplet digital Polymerase Chain Reaction) from comedones samples
Measured: Change from baseline to 2 months, for each group
Effect of the RV3278A on microorganisms
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
Measured: Change from baseline to 2 months
Effect of the RV3278A on metabolites
Metagenomic analysis on comedones samples
Measured: Change from baseline to 1 month
Effect of the RV3278A on lipids
Lipids PCR (Polymerase Chain Reaction) analysis done by SpiderMass tool from cigarette paper and comedones samples
Measured: Change from baseline to 2 months
Effect of the RV3278A on lipids
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
Measured: Change from baseline to 2 months
Effect of the RV3278A on hyperkeratosis
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
Measured: Change from baseline to 2 months
RV3278A product tolerance
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 Day 1 to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start20 Sep 2021
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal REYGAGNE, Principal investigator, Centre de Santé Sabouraud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640388
- Sponsor's protocol ID
- RV3278A20200403
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 7 Dec 2022
- 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 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Comparative and Multicentric Study, to Evaluate the Effect of the RV3278A - ET0943 on the Host/Micro-organism Relationships in Acneic Subjects
- ClinicalTrials.gov ID
- NCT05640388
- Acronym / sponsor ID
- RV3278A20200403
- Conditions
- Acne
- Keywords
- Comedones, Lipids, Blackheads, Host/Microorganism Relationship, Micro comedones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 7 Dec 2022 (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 the study is to understand the structural and functional modifications of the host, the microorganisms, and their interactions (host/microorganism relationship) before and after the RV3278A - ET0943 product application
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV3278A arm : Treated group | – | Other: RV3278A - ET0943 cosmetic productThis group will receive the RV3278A - ET0943 product |
| RV4632A arm : Control group | – | Other: RV4632A - RY1845 cosmetic productThis group will receive the RV4632A - RY1845 product |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects are enrolled during their usual medical care and/or from the database of the investigational sites. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the study.
Key inclusion criteria (6 listed)
- Related to the population:
- Related to diseases:
Key exclusion criteria (9 listed)
- Related to diseases:
- Related to the treatments/products:
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 |
|---|---|---|
| RV3278A - ET0943 cosmetic productRV3278A - ET0943 study product is applied twice a day on the face during the whole study. | Other | RV3278A arm : Treated group |
| RV4632A - RY1845 cosmetic productRV4632A - RY1845 study product must be applied only in case of sensation of skin discomfort | Other | RV4632A arm : Control group |
Primary outcome
Effect of the RV3278A on acne severity
Time frame: Change from baseline to 2 months
Global Evaluation Acne (GEA), on a 6-point scale 0: Clear. No lesions 1. Almost clear, Almost no lesions 2. Mild 3. Moderate 4. Severe 5. Very severe
Effect of the RV3278A on inflammatory and retentionnal lesions
Time frame: Change from baseline to 2 months
Quantification of inflammatory and retentionnal lesions from image analysis
Effect of the RV3278A on microorganisms
Time frame: Change from baseline to 2 months, for each group
Quantitative analysis by ddPCR (droplet digital Polymerase Chain Reaction) from comedones samples
Effect of the RV3278A on microorganisms
Time frame: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
Effect of the RV3278A on metabolites
Time frame: Change from baseline to 1 month
Metagenomic analysis on comedones samples
Effect of the RV3278A on lipids
Time frame: Change from baseline to 2 months
Lipids PCR (Polymerase Chain Reaction) analysis done by SpiderMass tool from cigarette paper and comedones samples
Effect of the RV3278A on lipids
Time frame: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
Effect of the RV3278A on hyperkeratosis
Time frame: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
RV3278A product tolerance
Time frame: From Day 1 to 2 months
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
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 7 Dec 2022.
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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.
Pascal REYGAGNE principal investigator
Centre de Santé Sabouraud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by Pierre Fabre Dermo Cosmetique at 2 sites in France.
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 6 inclusion and 9 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. 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 RV3278A on acne severity (time frame: Change from baseline to 2 months). The study lists 9 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 7 Dec 2022.