* 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Cosmetic product
Cosmetic product vehicle
Hbib thamer Hospital
Tunis, Tunisia
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;
Time frame: 4 months
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.
Time frame: 1 month, 2 months, 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.