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

Primary Purpose

Vitiligo

Status

Unknown status

Phase

Not Applicable

Locations

Tunisia

Study Type

Interventional

Intervention

Lithium liposome

Placebo

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

•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.

Sites / Locations

Hbib thamer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Lithium liposome and placebo A

Lithium liposome and placebo B

Lithium liposome and placebo C

Arm Description

• 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;

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;

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.

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04171427

First Posted

November 7, 2019

Last Updated

November 19, 2019

Sponsor

Laboratoire Dermatologique ACM

1. Study Identification

Unique Protocol Identification Number

NCT04171427

Brief Title

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

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 21, 2019 (Anticipated)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoire Dermatologique ACM

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Three parallel groups testing different dosages / combinations of treatments

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lithium liposome and placebo A

Arm Type

Other

Arm Description

Arm Title

Lithium liposome and placebo B

Arm Type

Other

Arm Description

Arm Title

Lithium liposome and placebo C

Arm Type

Other

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Lithium liposome

Intervention Description

Cosmetic product

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Cosmetic product vehicle

Primary Outcome Measure Information:

Title

the percentage of repigmentation

Description

• Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;

Time Frame

4 months

Secondary Outcome Measure Information:

Title

the percentage of repigmentation and acceptability

Description

Time Frame

1 month, 2 months, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samy FENNICHE

Organizational Affiliation

Hbib Thamer Hosptal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hbib thamer Hospital

City

Tunis

Country

Tunisia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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