HypersensitiveNCT05171556
IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Balm)
An observational study of Hypersensitive and Reactive and Intolerant Skin, run by Pierre Fabre Dermo Cosmetique at 1 site in China.
Trial summary
The aim of this study is to assess the dermatological and ophthalmological tolerance of the investigational product Baume visage / Face balm RV4942A - RY1985 after 21 days of twice daily use on the study areas, under normal conditions of use. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitive, Reactive and Intolerant Skin, Redness-prone Skin
- What is being tested?
- Cosmetic product
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 11 May 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 65 years included
- Asian population (Chinese origin)
- Dry to very dry skin on the face
- Subject with phototype I to IV included
- Subject having signed his/her written informed consent for his/her participation in the study
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- Subject who is currently not participating in another clinical study
- Subject affiliated to a social security system or health insurance, or is a beneficiary
- 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:
- Stinger subjects (evaluated by a stinger test)
- Subject with hypersensitive, reactive and intolerant skin on face
- Subject having a score superior to 4 on a sensitive scale for tightness parameter on the face
- Subject having a score superior to 4 on a sensitive scale for general discomfort parameter on the 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
- Having a dermatological condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Having an ophthalmological condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Having personal medical history liable to interfere with the study data for the subject or incompatible with the study requirements
- Having history of abnormal reactions from exposure to sunlight
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- Having taken any previous treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
- Being under any treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
- 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 investigational product application areas:
- Having had any surgery, chemical or significant invasive dermotreatment on the experimental area considered by the Investigator liable to interfere with the study data, before the inclusion visit or foreseeing it for the duration of the study
- Having applied a skincare or make up product on the study areas the day of the inclusion visit. The usual cleanser is allowed
- Having received, on the study areas, artificial UV exposure or excessive exposure to natural sunlight within the 2 weeks before the inclusion visit (at Investigator's opinion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT
The aim of this study is to assess the dermatological and ophthalmological tolerance of the investigational product Baume visage / Face balm RV4942A - RY1985 after 21 days of twice daily use on the study areas, under normal conditions of use.
The aim of this study is also to:
Read more
- evaluate the cutaneous sensitivity by a stinging test at D1 T0 and D22.
- evaluate the cutaneous sensitivity by a sensitive scale at D1 T0, D1 Timm*, D8 and D22.
- evaluate the soothing efficacy by an efficacy questionnaire at D1 Timm*, D8 and D22.
- evaluate the cosmetic acceptability by a questionnaire at D22.
This study is conducted as a national, monocentric, non-randomized open trial. The 33 subjects in this study (31 subjects on D22) present hypersensitive, reactive and intolerant skin on face. They are stinger subjects, with a dry to very dry skin.
Timm*: 10 to 30 minutes after first application
Read the detailed description
his study is a national, monocentric, non-randomized open trial, conducted in adults presenting hypersensitive, reactive and intolerant skin on the face, with a dry to very dry skin.
The study includes 3 visits, including subjects' selection:
- V1: Baseline inclusion
- V2: 1 week, intermediate visit
- V3: 3 weeks, study end
The maximal study duration is 25 days.
The evaluation is at 3 times: D1 baseline, D8 at 1 week and D22 at 3 weeks of application of RV4942A - RY1985 with comparison of each time versus baseline.
There are twice-daily applications (morning and evening) of the test product on the face.
- Being tested
- Cosmetic product
- Keywords
- Hypersensitive skin, Discomfort sensations, Asian skin, Sensitivity reduction
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic productOther
RV4942A is a face balm product
| Study group | Role | What they receive |
|---|---|---|
| RV4942A arm | RV4942A study product is applied twice a day (morning and evening) on the face, neck and eye contour during the whole study. Receives: Other: Cosmetic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global tolerance assessment of the investigational product by dermatological evaluation
Dermatological evaluation based on physical and functional signs assessment by the dermatologist
Measured: Change from baseline to just after application and to 3 weeks later
Global tolerance assessment of the investigational product by ophthalmological evaluation
Ophthalmological evaluation based on physical and functional signs assessment by the ophthalmologist
Measured: Change from baseline to just after application and to 3 weeks later
Secondary outcomes (4)
Cutaneous sensitivity by stinging test
Stinging test is an in vivo methodology that evaluates sensitive skin and consists in application of 10% lactic acid on one nasolabial fold of subject's nasogenian folds
Measured: Change from baseline to 3 weeks later
Cutaneous sensitivity by sensitivity scale questionnaire
Subjects assess the degree of their overall face skin irritation using an Analogue Visual Scale and fill out the sensitivity scale questionnaire regarding physical and functional cutaneous signs to score from 0 to 10.
Measured: Change from baseline to 1 week and to 3 weeks later
Soothing efficacy by a questionnaire
Subjects evaluate the soothing effect of the investigational product with a questionnaire
Measured: Change from just after application to 1 week and to 3 weeks later
Cosmetic acceptability and efficacy perceived questionnaire
Questionnaire with open questions and scales ranging from 0 to 10 where 0 was the worst satisfaction and 10 the best one.
Measured: After 3 weeks of tested product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start20 Apr 2021
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitiveStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lexi LIU, Study chair, EUROFINS CHINA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171556
- Sponsor's protocol ID
- RV4942A20200169
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 29 Dec 2021
- 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT
- ClinicalTrials.gov ID
- NCT05171556
- Acronym / sponsor ID
- RV4942A20200169
- Keywords
- Hypersensitive skin, Discomfort sensations, Asian skin, Sensitivity reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 29 Dec 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 assess the dermatological and ophthalmological tolerance of the investigational product Baume visage / Face balm RV4942A - RY1985 after 21 days of twice daily use on the study areas, under normal conditions of use.
The aim of this study is also to:
- evaluate the cutaneous sensitivity by a stinging test at D1 T0 and D22.
- evaluate the cutaneous sensitivity by a sensitive scale at D1 T0, D1 Timm*, D8 and D22.
- evaluate the soothing efficacy by an efficacy questionnaire at D1 Timm*, D8 and D22.
- evaluate the cosmetic acceptability by a questionnaire at D22.
This study is conducted as a national, monocentric, non-randomized open trial. The 33 subjects in this study (31 subjects on D22) present hypersensitive, reactive and intolerant skin on face. They are stinger subjects, with a dry to very dry skin.
Timm*: 10 to 30 minutes after first application
Detailed description
his study is a national, monocentric, non-randomized open trial, conducted in adults presenting hypersensitive, reactive and intolerant skin on the face, with a dry to very dry skin.
The study includes 3 visits, including subjects' selection:
- V1: Baseline inclusion
- V2: 1 week, intermediate visit
- V3: 3 weeks, study end
The maximal study duration is 25 days.
The evaluation is at 3 times: D1 baseline, D8 at 1 week and D22 at 3 weeks of application of RV4942A - RY1985 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
- 1
| Arm | Type | Receives |
|---|---|---|
| RV4942A arm | – | Other: Cosmetic productRV4942A study product is applied twice a day (morning and evening) on the face, neck and eye contour during the whole study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 (14 listed)
- Criteria related to the population:
- Criteria related to diseases and general health:
Key exclusion criteria (14 listed)
- Criteria related to the population:
- Criteria related to investigational product application areas:
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 productRV4942A is a face balm product | Other | RV4942A arm |
Primary outcome
Global tolerance assessment of the investigational product by dermatological evaluation
Time frame: Change from baseline to just after application and to 3 weeks later
Dermatological evaluation based on physical and functional signs assessment by the dermatologist
Global tolerance assessment of the investigational product by ophthalmological evaluation
Time frame: Change from baseline to just after application and to 3 weeks later
Ophthalmological evaluation based on physical and functional signs assessment by the ophthalmologist
4 secondary outcomes
Cutaneous sensitivity by stinging test
Time frame: Change from baseline to 3 weeks later
Cutaneous sensitivity by sensitivity scale questionnaire
Time frame: Change from baseline to 1 week and to 3 weeks later
Soothing efficacy by a questionnaire
Time frame: Change from just after application to 1 week and to 3 weeks later
Cosmetic acceptability and efficacy perceived questionnaire
Time frame: After 3 weeks of tested product
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 29 Dec 2021.
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.
Lexi LIU study chair
EUROFINS CHINA
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 Hypersensitive and Reactive and Intolerant Skin, run by Pierre Fabre Dermo Cosmetique at 1 site in China.
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 14 inclusion and 14 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 29 Dec 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 China. 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?
Global tolerance assessment of the investigational product by dermatological evaluation (time frame: Change from baseline to just after application and to 3 weeks later). The study lists 2 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 29 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.