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

Not Applicable

• Conditions: Vitiligo
• Interventions: Other: Lithium liposome; Other: Placebo

• Registration Number: NCT04171427
• Lead Sponsor: Laboratoire Dermatologique ACM

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20
• Study Start: 2019-11-21
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lithium liposome and placebo C	Lithium liposome	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.
Lithium liposome and placebo C	Placebo	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.
Lithium liposome and placebo B	Placebo	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;
Lithium liposome and placebo B	Lithium liposome	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;
Lithium liposome and placebo A	Lithium liposome	• 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;
Lithium liposome and placebo A	Placebo	• 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;

Primary Outcome Measures

Name	Time	Method
the percentage of repigmentation	4 months	• 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 Outcome Measures

Name	Time	Method
the percentage of repigmentation and acceptability	1 month, 2 months, 3 months	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.

Trial Locations

Locations (1)

Hbib thamer Hospital; 🇹🇳 Tunis, Tunisia