Clinical trial NCT04171427: Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo
Official title: Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo -Study Realized by a Dermatologist-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: Laboratoire Dermatologique ACM
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three parallel groups testing different dosages / combinations of treatments
Primary purpose: TREATMENT

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.

Eligibility criteria: •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.

Primary outcomes:
measure: the percentage of repigmentation
timeFrame: 4 months
Secondary outcomes:
measure: the percentage of repigmentation and acceptability
timeFrame: 1 month, 2 months, 3 months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Hbib thamer Hospital
Study officials:
affiliation: Hbib Thamer Hosptal
name: Samy FENNICHE
role: PRINCIPAL_INVESTIGATOR
References: