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

NCT ID: NCT04171427

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2020-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lithium liposome and placebo A

• 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;

Group Type: OTHER

Lithium liposome

Intervention Type: OTHER

Cosmetic product

Placebo

Intervention Type: OTHER

Cosmetic product vehicle

Lithium liposome and placebo B

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;

Group Type: OTHER

Lithium liposome

Intervention Type: OTHER

Cosmetic product

Placebo

Intervention Type: OTHER

Cosmetic product vehicle

Lithium liposome and placebo C

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.

Group Type: OTHER

Lithium liposome

Intervention Type: OTHER

Cosmetic product

Placebo

Intervention Type: OTHER

Cosmetic product vehicle

Interventions

Lithium liposome

Cosmetic product

Intervention Type: OTHER

Placebo

Cosmetic product vehicle

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratoire Dermatologique ACM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samy FENNICHE

Role: PRINCIPAL_INVESTIGATOR

Hbib Thamer Hosptal

Locations

Hbib thamer Hospital

Tunis, , Tunisia

Countries

Tunisia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18E1721

Identifier Type: -

Identifier Source: org_study_id