Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo

Study Overview
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Brief Summary
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Study in proof of concept; Double blind study; Comparative study, versus placebo in intra-individual Three parallel groups testing different dosages / combinations of treatments Randomized.

Detailed Description
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This study has as objectives: Primary objective : • Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis; Secondary objectives: Evaluate: the percentage of repigmentation observed after one, two and three months of treatment measured on an objective layer by image analysis; the ability of the product to maintain the human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist; Patient satisfaction using a visual analogue scale from 0 to 10. The illustrative effect using standardized photographs; The quantity of product by weighing the tubes. The occurrence of possible adverse effects. Population: Sexe: female and male; Age: over 18 years old; Patients with stable non-segmental vitiligo lesions (defined as no new lesions or lesions that have been present for at least 3 months, lack of hypochromic margins in Wood's lumen and absence of confetti depigmentation); Patients with 2 to 6 symmetrical lesions (1 to 3 on each side). These lesions (macules) will be treated for a minimum surface of 2 cm² and a maximum surface of 100 cm².

Official Title
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Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo -Study Realized by a Dermatologist-

Conditions
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Vitiligo

Intervention / Treatment
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* Other: Lithium liposome
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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•Inclusion Criteria: Sexe: female and male; Age: over 18 years old; Patients with stable non-segmental vitiligo lesions (defined as no new lesions or lesions that have been present for at least 3 months, lack of hypochromic margins in Wood's lumen and absence of confetti depigmentation); Patients with 2 to 6 symmetrical lesions (1 to 3 on each side). These lesions (macules) will be treated for a minimum surface of 2 cm² and a maximum surface of 100 cm². Healthy volunteer; Volunteer having given in writing his free, informed and express consent; Volunteer willing to abide by the protocol and procedures of the study. Exclusion Criteria: Pregnant woman or woman who is breastfeeding or planning for early pregnancy during the study; Patient with segmental or mixed vitiligo; Patient with vitiligo of the external genitalia; Patient with vitiligo touching hands and feet only Patient with a history of skin cancer or pre-cancerous skin lesions; Patient taking topical or systemic vitiligo treatments in the month prior to the start of the study; Patient taking concomitant local or general corticosteroid therapy or immunomodulatory therapy; Patient with a history of photodermatoses or taking photosensitizing medications; Patient having planned to expose himself (artificial sun or UV) during the study at the level of the zones to be treated and / or having been exposed during the month preceding the beginning of the study and having an acquired pigmentation (tanning) obvious; Patient who had been treated with phototherapy within 4 weeks before randomization; Patient with lithium allergy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three parallel groups testing different dosages / combinations of treatments
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lithium liposome and placebo A<br>• Group A : 4 patients; Lithium liposome 1 application / day (evening) on target lesions on one side of the body, placebo 1 application / day (evening) on contralateral target lesions and excimer lamp on target lesions on the two sides; | Other: Lithium liposome<br>* Cosmetic product<br>Other: Placebo<br>* Cosmetic product vehicle<br>|
| Other: Lithium liposome and placebo B<br>Group B : 4 patients; Liposomal Lithium 2 applications / day (morning and evening) on target lesions on one side of the body, placebo 2 applications / day (morning and evening) on contralateral target lesions and excimer lamp on target lesions on the two sides; | Other: Lithium liposome<br>* Cosmetic product<br>Other: Placebo<br>* Cosmetic product vehicle<br>|
| Other: Lithium liposome and placebo C<br>Groupe C : 4 patients; Lithium liposome 2 applications / day (morning and evening) on one side, placebo 2 applications / day (morning and evening) on contralateral target lesions. | Other: Lithium liposome<br>* Cosmetic product<br>Other: Placebo<br>* Cosmetic product vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of repigmentation | • Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis; | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of repigmentation and acceptability | the percentage of repigmentation observed after one, two and three months of treatment measured on an objective layer by image analysis; the ability of the product to maintain the human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist; Patient satisfaction using a visual analogue scale from 0 to 10. The illustrative effect using standardized photographs; The quantity of product by weighing the tubes. The occurrence of possible adverse effects. | 1 month, 2 months, 3 months |