VitiligoNCT06446063
Efficacy & Tolerance of Cosmetic Product RV5098A on Face Pigmentation Maintenance in Adult Vitiligo Patients.
An observational study of Vitiligo, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
Vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. Vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Test product
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2024to 31 Oct 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be enrolled from the investigator's outpatient's reception and/or from the database of the centre. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.
Who may be able to join
- Criteria related to the population:
- Subject aged between 18 and 75 years included.
- Criteria related to the disease:
- Subject with facial vitiligo, regardless of its duration.
- having a sufficient repigmentation rate of the vitiligo after repigmenting treatment
- Criteria related to treatments and/or products:
Show all 17Show fewer
- Subject responder to a repigmenting treatment
- Non-inclusion Criteria:
- Criteria related to the diseases / skin condition:
- Subject with active vitiligo.
- Subject with spontaneous repigmentation without treatment.
- Subject having other dermatological condition, an acute, chronic, or progressive disease or history of disease liable to interfere with the study assessments or considered by the Investigator hazardous for the subject or incompatible with the study requirements.
- Criteria related to treatments and/or products:
- Systemic immunomodulatory treatment taken for another pathology, before inclusion, on-going or planned to be established during the study.
- Any topical immunomodulatory treatment applied on the face for another pathology, on-going or planned to be established during the study.
- Any other 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 evaluation of the efficacy according to the investigator's assessment.
- Any dietary supplement for vitiligo within 4 weeks before the inclusion visit or planned to be established during the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerance of the Cosmetic Care Product RV5098A on the Maintenance of Pigmentation on Face in Adult Patients With Vitiligo.
Vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. Vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically predisposed patient.
Despite major advances in the understanding of the mechanisms of the disease, the treatment remains challenging. Different treatment strategies could lead to cosmetically acceptable repigmentation (>75%), particularly on face and neck. However, after repigmentation, the risk of relapse is estimated at nearly 40% during the first year after stopping treatment.
To date, long-term management remains a challenge. With their topical product RV5098A adapted for patients with vitiligo, Pierre Fabre Laboratories hypothesize that it could be effective in maintaining pigmentation of previously repigmented lesions in adults with facial vitiligo.
- Conditions
- Vitiligo
- Being tested
- Test product, Control Product
- Keywords
- Vitiligo, Adults, Face, Repigmented, Maintenance of repigmentation
- Medical subject headings
- Vitiligo, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test productOther
Twice daily applications The product is applied to the entire face.
Control ProductOther
Twice daily applications The product is applied to the entire face.
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Not described Receives: Other: Test product | |
| Control group | Not described Receives: Other: Control Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo
assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)
Measured: assessed after 24 weeks of use
Secondary outcomes (10)
Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the investigator
assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)
Measured: assessed after 12 weeks of use
Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the subject
assessed by the subject on the face on a 7-point scale (from very much worse to very much improved)
Measured: assessed after 12 and 24 weeks of use and monthly at home
Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the investigator
assessed by the investigator on the face on a vitiligo severity scale from 0 (absent) to 3 (complete depigmentation)
Measured: assessed at baseline and after 12 and 24 weeks of use.
Efficacy of the test product RV5098A on the maintenance of pigmentation by the extent of facial vitiligo
assessed by the investigator on the face with score of extent of vitiligo
Measured: assessed at baseline and after 12 and 24 weeks of use.
Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the subject
assessed by the subject on the face on a 5-point scale (from no vitiligo to very severe)
Measured: assessed at baseline, after 12 and 24 weeks of use and monthly at home
Efficacy of the test product RV5098A on the maintenance of pigmentation by the impact on quality of life assessed by the patient
assessed by the subject with quality-of-life questionnaire
Measured: assessed at baseline, after 12 and 24 weeks of use
Efficacy of the test product RV5098A on the maintenance of pigmentation by imaging quantification.
Measurement of depigmentation surface on a target lesion of the face by the investigator.
Measured: assessed at baseline, after 12 and 24 weeks of use.
Cosmetic satisfaction and perceived effects as regards to the use of the test product RV5098A by Cosmetic acceptability questionnaire assessed by the patient
A questionnaire with a scale from 0 to 10 responding to statements about the sensorial experience and effect of the product (0=not at all agree, 10=completely agree).
Measured: assessed after 12 and 24 weeks of use.
Global tolerance of the test product RV5098A assessed by the investigator.
assessed by the investigator with 5-point scale (from bad to excellent)
Measured: assessed after 24 weeks of use.
Compliance of the subjects to the test product RV5098A
The subject will report his/her compliance in a subject's diary
Measured: through study completion, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start23 May 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien SENESCHAL, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446063
- Sponsor's protocol ID
- RV5098A20230158
- Status last verified
- May 2026
- First submitted
- 7 May 2024
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of the Cosmetic Care Product RV5098A on the Maintenance of Pigmentation on Face in Adult Patients With Vitiligo.
- ClinicalTrials.gov ID
- NCT06446063
- Acronym / sponsor ID
- RV5098A20230158
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Adults, Face, Repigmented, Maintenance of repigmentation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 23 May 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 6 Jun 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.
Vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. Vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically predisposed patient.
Despite major advances in the understanding of the mechanisms of the disease, the treatment remains challenging. Different treatment strategies could lead to cosmetically acceptable repigmentation (>75%), particularly on face and neck. However, after repigmentation, the risk of relapse is estimated at nearly 40% during the first year after stopping treatment.
To date, long-term management remains a challenge. With their topical product RV5098A adapted for patients with vitiligo, Pierre Fabre Laboratories hypothesize that it could be effective in maintaining pigmentation of previously repigmented lesions in adults with facial vitiligo.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | – | Other: Test product |
| Control group | – | Other: Control Product |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled from the investigator's outpatient's reception and/or from the database of the centre. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.
Key inclusion criteria (17 listed)
- Subject aged between 18 and 75 years included.
- Subject with facial vitiligo, regardless of its duration.
- having a sufficient repigmentation rate of the vitiligo after repigmenting treatment
- Subject responder to a repigmenting treatment
- Subject with active vitiligo.
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 productTwice daily applications The product is applied to the entire face. | Other | Treated group |
| Control ProductTwice daily applications The product is applied to the entire face. | Other | Control group |
Primary outcome
Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo
Time frame: assessed after 24 weeks of use
assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)
10 secondary outcomes
Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the investigator
Time frame: assessed after 12 weeks of use
Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the subject
Time frame: assessed after 12 and 24 weeks of use and monthly at home
Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the investigator
Time frame: assessed at baseline and after 12 and 24 weeks of use.
Efficacy of the test product RV5098A on the maintenance of pigmentation by the extent of facial vitiligo
Time frame: assessed at baseline and after 12 and 24 weeks of use.
Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the subject
Time frame: assessed at baseline, after 12 and 24 weeks of use and monthly at home
Efficacy of the test product RV5098A on the maintenance of pigmentation by the impact on quality of life assessed by the patient
Time frame: assessed at baseline, after 12 and 24 weeks of use
Efficacy of the test product RV5098A on the maintenance of pigmentation by imaging quantification.
Time frame: assessed at baseline, after 12 and 24 weeks of use.
Cosmetic satisfaction and perceived effects as regards to the use of the test product RV5098A by Cosmetic acceptability questionnaire assessed by the patient
Time frame: assessed after 12 and 24 weeks of use.
Global tolerance of the test product RV5098A assessed by the investigator.
Time frame: assessed after 24 weeks of use.
Compliance of the subjects to the test product RV5098A
Time frame: through study completion, 6 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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.
Julien SENESCHAL, Pr principal investigator
University Hospital, Bordeaux
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 Vitiligo, 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 17 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: stopped early, as of the sponsor's last update on 8 May 2026. 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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 test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo (time frame: assessed after 24 weeks of use). 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 8 May 2026.