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-

Patrocinadores

Patrocinador principal: Laboratoire Dermatologique ACM

Fuente Laboratoire Dermatologique ACM
Resumen breve

- 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.

Descripción detallada

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.

Estado general Enrolling by invitation
Fecha de inicio November 21, 2019
Fecha de Terminación May 2020
Fecha de finalización primaria May 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
the percentage of repigmentation 4 months
Resultado secundario
Medida Periodo de tiempo
the percentage of repigmentation and acceptability 1 month, 2 months, 3 months
Inscripción 12
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Lithium liposome

Descripción: Cosmetic product

Tipo de intervención: Other

Nombre de intervención: Placebo

Descripción: Cosmetic product vehicle

Elegibilidad

Criterios:

•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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Samy FENNICHE Principal Investigator Hbib Thamer Hosptal
Ubicación
Instalaciones: Hbib thamer Hospital
Ubicacion Paises

Tunisia

Fecha de verificación

October 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Lithium liposome and placebo A

Tipo: Other

Descripción: • 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;

Etiqueta: Lithium liposome and placebo B

Tipo: Other

Descripción: 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;

Etiqueta: Lithium liposome and placebo C

Tipo: Other

Descripción: 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.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Three parallel groups testing different dosages / combinations of treatments

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov