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

Vitiligo Clinical Trial

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

Status Enrolling by invitation

Clinical Trial Summary

• 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Vitiligo

• NCT number: NCT04171427
• Study type: Interventional
• Source: Laboratoire Dermatologique ACM
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 21, 2019
• Completion date: May 2020