AcneNCT04873089
Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin
An observational study of Acne, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
The aim of this study is to evaluate, at different times, the RV3278A - ET0943 cosmetic product efficacy after 8 weeks of application on the face (twice-daily application). At T1 (Baseline), T2 (4 weeks) and T3 (8 weeks), the following assessments are performed: The reduction of the pilosebaceous follicular ostium… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Cosmetic product
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2018to 21 Dec 2018
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects have been recruited from the panel of the centre. An investigator made a dermatological examination of the subjects before inscription in the panel. Data from this clinical examination, stored in the computer database with the consent of the subjects, can ensure the recruitment; computer software being questioned based on the eligibility criteria of the study.
Who may be able to join
- Criteria related to the population:
- Male or Female aged between 18 and 35 years included
- Subject with phototype I to IV included
- Subject having signed his/her written informed consent for his/her participation in the study
- Subject who is currently not participating in another clinical study
- Subject affiliated to a social security system or health insurance, or is a beneficiary
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- For woman of childbearing potential: use of an effective method of contraception and using it during the whole duration of the study
- Criteria related to diseases and general health:
- Subject with oily, blemished skin and dilated pores on the face including open and closed comedones of the retention type (on the forehead, temporal areas and nose wings) and some inflammatory lesions:
- Retention aspect: microcomedones and open comedones count on the forehead (> 10)
- Inflammatory aspect: lesions ≤ 10 count on the whole face
Who cannot join
- Criteria related to the population:
- For woman of childbearing potential: subject pregnant or breastfeeding or planning to be pregnant during the study
- Subject having already known allergy to latex
- Subject having already known allergy to the test product or associated product components
- Subject having scar(s) or other skin characteristic on the study areas (forehead, temporal areas and nose wings) and which, size is not compatible with the study realization
- Subject who, has planned to apply exfoliating, keratolytic and/or self-tanning products on the face within 2 weeks prior to inclusion.
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- Subject who, has planned to be exposed to the natural or artificial UV during the study
- Subject who is not likely to be compliant with study-related requirements
- Subject deprived of freedom by administrative or legal decision or under guardianship
- Criteria related to diseases and general health:
- Inflammatory or immunological dermatosis (atopic dermatitis, psoriasis, severe inflammatory acne, cutaneous seborrhoeic dermatitis, vitiligo of the face..) of the face, or other dermatological face illness in progress at the time of inclusion on the sample areas (pigmentation of the sample areas by melasma, solar erythema or artificial post UV...)
- Criteria related to treatments
- Facial treatments :
- Any topical anti-acne antibiotics (topical Erythromycin or topical Dalacin) applied during more than 5 consecutive days within 4 weeks before the inclusion
- Any topical treatment (dermo corticoids, retinoids, antibiotics, antifungals…) ongoing or applied within 4 weeks before the inclusion
- Oral intake of antibiotic, zinc gluconate or hormonal anti-acne treatments, ongoing or taken during more than 5 consecutive days within the month before the inclusion
- Oral intake of isotretinoin within 6 months before the inclusion
- Anti-inflammatory treatments (steroids or no steroids) according to the investigator's assessment
- Hormonal contraception established or modified within 3 months before the inclusion
- Application of skin care product containing exfoliating, keratolytic or self-tanning ingredients applied on the face within 15 days before the inclusion
- Oral treatment (cardiovascular, endocrinal, rheumatological, urogenital, neuropsychiatric, immunosuppressant) established within 2 months before the inclusion not stabilized
- Hygiene, skin care or make-up habits modified within less than one month before the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RV3278AET0943 Cosmetic Product Efficacy Applied for 8 Weeks in Adults Having Oily and Acne Prone Skin: Comparative Study Versus Not Treated Group
The aim of this study is to evaluate, at different times, the RV3278A - ET0943 cosmetic product efficacy after 8 weeks of application on the face (twice-daily application). At T1 (Baseline), T2 (4 weeks) and T3 (8 weeks), the following assessments are performed:
- The reduction of the pilosebaceous follicular ostium size in vivo (pores) on the forehead
- The clinical evaluation (count of non inflammatory and inflammatory acne lesions, IGA score) of the face
- The reduction in visible follicles
- The standardized numerical photographs of face and ¾ right and left profile in normal, parallel polarized, cross polarized and UV light
- The analysis of the skin lipids of the forehead
- The qualitative and quantitative analysis of the sebum and comedones constituents (nose wings)
Read more
This is a comparative, open-labelled study, on subjects with oily and acne prone skins on the face.
Each group includes 18 subjects.
Read the detailed description
This study is monocentric, comparative versus non-treated group, open-labelled, exploratory, conducted in adults having oily and acne prone skin.
The study includes 4 visits for each group, including subjects' selection:
- V0: Subjects' selection
- V1: Baseline inclusion
- V2: 4 weeks, follow-up visit
- V3: 8 weeks, study end
The maximal study duration is 61 days. The front, temporal areas and nose wings are defined as the study interest areas for superficial samples.
The evaluation is at 3 times: T1 baseline, T2 at 4 weeks and T3 at 8 weeks of application of RV3278A formula ET0943 with comparison of each time versus baseline.
There are twice-daily applications (morning and evening) of the test product on the face.
- Conditions
- Acne
- Being tested
- Cosmetic product
- Keywords
- Lipids, Biometrological, Microcomedomes, Sebum, Fatty acids, Phytotherapy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic productOther
It is a comparative study with two parallel groups of subjects:
- Tested group: twice daily application of the cream RV3278A cosmetic product on the whole face
- Comparative group: no application of study product or reference product
| Study group | Role | What they receive |
|---|---|---|
| RV3278A arm | RV3278A study product is applied twice a day (morning and evening) on the face during the whole study. Receives: Other: Cosmetic product | |
| Control Group | Subjects included in the control group did not receive the test product or other associated product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the product on lesions count (Lucky method)
Inflammatory and lesions quantification on the whole face
Measured: Change from baseline to 8 weeks later, for each group
Secondary outcomes (11)
Efficacy of the product on lesions count (Lucky method)
Inflammatory and lesions quantification on the whole face
Measured: Change from baseline to 4 weeks later, for each group
Forehead acne lesions count (target area)
Measured: Change from baseline to 4 weeks and 8 weeks later for each group, on the target area
Investigator Global Assessment (IGA) on 5-point scale
Clear = 0, Almost clear = 1, Mild = 2, Moderate = 3, Severe = 4
Measured: Change from 4 weeks to 8 weeks later, for each group, on the target area
Sebum harvest and analysis
Quantification of free fatty acid (FFA) / triglyceride (TG) ratio by infrared spectroscopy: Forehead sebum was collected on absorbent paper then the lipid composition was analysed by infrared spectroscopy to determine the free fatty acids to triglycerides ratio
Measured: At baseline and after one month of tested product treatment
Comedones lipid harvest and analysis
Quantification of free fatty acid / triglyceride ratio by GC/MS: Samples were collected with patch on nose wings. Comedones were collected and lipids extracted according to the Bligh \& Dyer (Bligh and Dyer, 1959). The biochemical exploration was performed by the screening of neutral lipids on GC/MS
Measured: At baseline and after one month of tested product treatment
Skin lipids
Measure by FTIR spectroscopy (in vivo non invasive infrared analysis)
Measured: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Pilosebaceous follicular ostium size in vivo
Measure by confocal microscope
Measured: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Dilated pores on 5-point scale
Absent = 0, Very mild = 1, Mild = 2, Moderate = 3, Severe = 4
Measured: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Patient Global Assessment (PGA) on 6-points scale
Clear worsening = 0, slight worsening = 1, no change = 2, slight improvement = 3, clear improvement = 4, total improvement = 5
Measured: Change from 4 weeks to 8 weeks later, for each group, on the target area
Self product agreement questionnaire
9-question questionnaire with a majority of scales ranging from 0 to 10 where 0 was the worst satisfaction and 10 the best one
Measured: At week 8, for tested group
Visible follicles quantification by in vivo visualisation methods
Count by multispectral imaging
Measured: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start17 Sep 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thérèse NOCERA, MD dermatologist, Principal investigator, SKIN RESEARCH CENTRE - Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873089
- Sponsor's protocol ID
- RV3278A2018243
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 5 May 2021
- 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 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RV3278AET0943 Cosmetic Product Efficacy Applied for 8 Weeks in Adults Having Oily and Acne Prone Skin: Comparative Study Versus Not Treated Group
- ClinicalTrials.gov ID
- NCT04873089
- Acronym / sponsor ID
- RV3278A2018243
- Conditions
- Acne
- Keywords
- Lipids, Biometrological, Microcomedomes, Sebum, Fatty acids, Phytotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 5 May 2021 (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, at different times, the RV3278A - ET0943 cosmetic product efficacy after 8 weeks of application on the face (twice-daily application). At T1 (Baseline), T2 (4 weeks) and T3 (8 weeks), the following assessments are performed:
- The reduction of the pilosebaceous follicular ostium size in vivo (pores) on the forehead
- The clinical evaluation (count of non inflammatory and inflammatory acne lesions, IGA score) of the face
- The reduction in visible follicles
- The standardized numerical photographs of face and ¾ right and left profile in normal, parallel polarized, cross polarized and UV light
- The analysis of the skin lipids of the forehead
- The qualitative and quantitative analysis of the sebum and comedones constituents (nose wings)
This is a comparative, open-labelled study, on subjects with oily and acne prone skins on the face.
Each group includes 18 subjects.
Detailed description
This study is monocentric, comparative versus non-treated group, open-labelled, exploratory, conducted in adults having oily and acne prone skin.
The study includes 4 visits for each group, including subjects' selection:
- V0: Subjects' selection
- V1: Baseline inclusion
- V2: 4 weeks, follow-up visit
- V3: 8 weeks, study end
The maximal study duration is 61 days. The front, temporal areas and nose wings are defined as the study interest areas for superficial samples.
The evaluation is at 3 times: T1 baseline, T2 at 4 weeks and T3 at 8 weeks of application of RV3278A formula ET0943 with comparison of each time versus baseline.
There are twice-daily applications (morning and evening) of the test product on the face.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV3278A arm | – | Other: Cosmetic productRV3278A study product is applied twice a day (morning and evening) on the face during the whole study. |
| Control Group | – | –Subjects included in the control group did not receive the test product or other associated product |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects have been recruited from the panel of the centre. An investigator made a dermatological examination of the subjects before inscription in the panel. Data from this clinical examination, stored in the computer database with the consent of the subjects, can ensure the recruitment; computer software being questioned based on the eligibility criteria of the study.
Key inclusion criteria (11 listed)
- Criteria related to the population:
- Criteria related to diseases and general health:
Key exclusion criteria (22 listed)
- Criteria related to the population:
- Criteria related to diseases and general health:
- Criteria related to treatments
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 |
|---|---|---|
| Cosmetic productIt is a comparative study with two parallel groups of subjects: * Tested group: twice daily application of the cream RV3278A cosmetic product on the whole face * Comparative group: no application of study product or reference product | Other | RV3278A arm |
Primary outcome
Efficacy of the product on lesions count (Lucky method)
Time frame: Change from baseline to 8 weeks later, for each group
Inflammatory and lesions quantification on the whole face
11 secondary outcomes
Efficacy of the product on lesions count (Lucky method)
Time frame: Change from baseline to 4 weeks later, for each group
Forehead acne lesions count (target area)
Time frame: Change from baseline to 4 weeks and 8 weeks later for each group, on the target area
Investigator Global Assessment (IGA) on 5-point scale
Time frame: Change from 4 weeks to 8 weeks later, for each group, on the target area
Sebum harvest and analysis
Time frame: At baseline and after one month of tested product treatment
Comedones lipid harvest and analysis
Time frame: At baseline and after one month of tested product treatment
Skin lipids
Time frame: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Pilosebaceous follicular ostium size in vivo
Time frame: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Dilated pores on 5-point scale
Time frame: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Patient Global Assessment (PGA) on 6-points scale
Time frame: Change from 4 weeks to 8 weeks later, for each group, on the target area
Self product agreement questionnaire
Time frame: At week 8, for tested group
Visible follicles quantification by in vivo visualisation methods
Time frame: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
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 5 May 2021.
- 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.
Thérèse NOCERA, MD dermatologist principal investigator
SKIN RESEARCH CENTRE - Toulouse
1 site 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 1 site 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 11 inclusion and 22 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 5 May 2021. 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 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?
Efficacy of the product on lesions count (Lucky method) (time frame: Change from baseline to 8 weeks later, for each group). 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 5 May 2021.