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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04171427
• Other study ID #: 18E1721
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: May 2020

Study information

• Verified date: October 2019
• Source: Laboratoire Dermatologique ACM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

•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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Other:
• Lithium liposome
Cosmetic product
• Placebo
Cosmetic product vehicle

Locations

Country	Name	City	State
Tunisia	Hbib thamer Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire Dermatologique ACM

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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