Clinical trial NCT06446063: Efficacy & Tolerance of Cosmetic Product RV5098A on Face Pigmentation Maintenance in Adult Vitiligo Patients.
Official title: Efficacy and Tolerance of the Cosmetic Care Product RV5098A on the Maintenance of Pigmentation on Face in Adult Patients With Vitiligo.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vitiligo
Keywords: Vitiligo
Adults
Face
Repigmented
Maintenance of repigmentation
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

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:

- 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.

Primary outcomes:
measure: Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo
timeFrame: assessed after 24 weeks of use
Secondary outcomes:
measure: Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the investigator
timeFrame: assessed after 12 weeks of use
measure: Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the subject
timeFrame: assessed after 12 and 24 weeks of use and monthly at home
measure: Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the investigator
timeFrame: assessed at baseline and after 12 and 24 weeks of use.
measure: Efficacy of the test product RV5098A on the maintenance of pigmentation by the extent of facial vitiligo
timeFrame: assessed at baseline and after 12 and 24 weeks of use.
measure: Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the subject
timeFrame: assessed at baseline, after 12 and 24 weeks of use and monthly at home
measure: Efficacy of the test product RV5098A on the maintenance of pigmentation by the impact on quality of life assessed by the patient
timeFrame: assessed at baseline, after 12 and 24 weeks of use
measure: Efficacy of the test product RV5098A on the maintenance of pigmentation by imaging quantification.
timeFrame: assessed at baseline, after 12 and 24 weeks of use.
measure: Cosmetic satisfaction and perceived effects as regards to the use of the test product RV5098A by Cosmetic acceptability questionnaire assessed by the patient
timeFrame: assessed after 12 and 24 weeks of use.
measure: Global tolerance of the test product RV5098A assessed by the investigator.
timeFrame: assessed after 24 weeks of use.
measure: Compliance of the subjects to the test product RV5098A
timeFrame: through study completion, 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: COSDERMA
state: Gironde
Study officials:
affiliation: University Hospital, Bordeaux
name: Julien SENESCHAL, Pr
role: PRINCIPAL_INVESTIGATOR
References: