Vitiligo
Conditions
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.
Interventions
OTHERLithium liposome
Cosmetic product
OTHERPlacebo
Cosmetic product vehicle
Sponsors
Laboratoire Dermatologique ACM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Three parallel groups testing different dosages / combinations of treatments
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the percentage of repigmentation | 4 months | • 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
| Measure | Time frame | Description |
|---|---|---|
| the percentage of repigmentation and acceptability | 1 month, 2 months, 3 months | 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. |
Countries
Tunisia
Outcome results
None listed