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

NCT04171427 | Unknown DMC

• 1 other identifier: 18E1721
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the percentage of repigmentation and acceptability

  1 month, 2 months, 3 months

Study Arms (3)

Lithium liposome and placebo A

OTHER

• 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; Other: Placebo

Lithium liposome and placebo B

OTHER

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; Other: Placebo

Lithium liposome and placebo C

OTHER

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; Other: Placebo

Interventions

Lithium liposome OTHER

Cosmetic product

Lithium liposome and placebo A; Lithium liposome and placebo B; Lithium liposome and placebo C

Placebo OTHER

Cosmetic product vehicle

Lithium liposome and placebo A; Lithium liposome and placebo B; Lithium liposome and placebo C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoire Dermatologique ACM: lead

Study Sites (1)

Hbib thamer Hospital

Tunis, Tunisia

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Samy FENNICHE

  Hbib Thamer Hosptal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three parallel groups testing different dosages / combinations of treatments

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 20, 2019
• Study Start: November 21, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)