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-

• 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.

Study Overview

• Status: Unknown
• Conditions: Vitiligo
• Intervention / Treatment: Other: Lithium liposome; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia
    • Hbib thamer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

•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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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;	Other: Lithium liposome; Cosmetic product; Other: Placebo; Cosmetic product vehicle
Other: 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;	Other: Lithium liposome; Cosmetic product; Other: Placebo; Cosmetic product vehicle
Other: 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.	Other: Lithium liposome; Cosmetic product; Other: Placebo; Cosmetic product vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of repigmentation	• Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of repigmentation and acceptability	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.	1 month, 2 months, 3 months

Collaborators and Investigators

• Sponsor: Laboratoire Dermatologique ACM
• Investigators: Principal Investigator: Samy FENNICHE, Hbib Thamer Hosptal

Study record dates

Study Major Dates

• Study Start (Anticipated): November 21, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: 18E1721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No