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Lack of recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group |
| ||
| Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product | Other | Twice daily applications The product is applied to the entire face. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | assessed after 24 weeks of use |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Inclusion Criteria:
Criteria related to the population:
- Subject aged between 18 and 75 years included.
Criteria related to the disease:
Criteria related to treatments and/or products:
- Subject responder to a repigmenting treatment
Non-inclusion Criteria:
Criteria related to the diseases / skin condition:
Criteria related to treatments and/or products:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Julien SENESCHAL, Pr | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| COSDERMA | Bordeaux | Gironde | 33000 | France |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| D019066 | Facies |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Product |
| Other |
Twice daily applications The product is applied to the entire face. |
|
assessed by the subject on the face on a 7-point scale (from very much worse to very much improved) |
| 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) | 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 | 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) | 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 | 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. | 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). | 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) | 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 | through study completion, 6 months |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |