NCT04171427

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Laboratoire Dermatologique ACM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Vitiligo

Interventions

Type	Name	Description
OTHER	Lithium liposome	Cosmetic product
OTHER	Placebo	Cosmetic product vehicle

Timeline

• Start date: 2019-11-21
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2019-11-20
• Last updated: 2019-11-20

Locations

1 site across 1 country: Tunisia