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

Laboratoire Dermatologique ACM

Status: Unknown

Conditions: Vitiligo

Treatments: Other: Lithium liposome; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04171427

18E1721

Details and patient eligibility

About

• 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.

Full description

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

•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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 3 patient groups

Lithium liposome and placebo A

Other group

Description:

• 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;

Treatment:

Other: Lithium liposome

Other: Placebo

Lithium liposome and placebo B

Other group

Description:

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;

Treatment:

Other: Lithium liposome

Other: Placebo

Lithium liposome and placebo C

Other group

Description:

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.

Treatment:

Other: Lithium liposome

Other: Placebo