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Vitiligo clinical trials

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NCT ID: NCT01841008 Terminated - Vitiligo Clinical Trials

Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control

Start date: December 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many prospective studies. Prospective randomized studies versus placebo are required to confirm the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1% per week can reduce relapses of non-segmental vitiligo lesions. Main objective To assess the efficacy of maintenance therapy with topical tacrolimus vs placebo in the prevention of depigmentation in patients with vitiligo who responded to treatment. Secondary objectives - Evaluate the efficacy of maintenance therapy with tacrolimus vs topical placebo to decrease the intensity of depigmentation in patients with vitiligo who responded to treatment. - To study the occurrence of possible adverse effects. Length of the study Inclusion: 12 months Treatment: 6 months Follow-up: 6 months Total length of the study: 18 months Intervention Multicentric prospective interventional randomized comparative study versus placebo. - Visit V0: Selection Information of the patient, control of inclusion and non inclusion criteria. - Visit V1: Control of inclusion and non inclusion criteria, patients signed informed consent. An initial clinical evaluation and photographs in direct sunlight and UV. Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks. - Visit V2: The patient will be reviewed after the end of treatment (24 weeks after the visit V1) for final evaluation. A clinical assessment will be made and photographs in the same way as the inclusion. Adverse reactions during treatment will be collected by the investigator (they will be noted as and when the patient in a notebook that will be presented at baseline). The percentage of depigmentation will be evaluated in a blinded treatment of photographs by two reviewers. In case of disagreement, the opinion of a third appraiser will be required. - End of study: After the end of the study patients will be supported via the usual care recommended for their condition. Evaluation criteria - primary endpoint ---Percentage of patients at 24 weeks without depigmentation (depigmentation score = 0). A score of depigmentation from 0 to 2 will be used. A blind treatment evaluation of direct light and UV photographs will be made by two independent observers (dermatologists) between inclusion and after 24 weeks of treatment. - secondary endpoints ---- The efficiency to reduce the intensity of relapses will be evaluated using the score of depigmentation (rate of patients with a score of 0 or 1 in each group) and the VASI score (Appendix 4). - The frequency, severity and time of occurrence of adverse events are reported. Side effects are classified into grades according to WHO criteria. Number of subject Considering that depigmentation occurs in more than 40% of patients during the 24 weeks of maintenance treatment and hoped that the proactive treatment will reduce the rate of depigmentation of 10%, a population of 26 patients per group will be necessary (taking into account 10% of patients lost to follow). The total number of patients to be included in the study will be 52.

NCT ID: NCT01262547 Terminated - Vitiligo Clinical Trials

A New Micrografting Technique for Vitiligo

Start date: September 2011
Phase: Phase 2
Study type: Interventional

This study evaluates micrografting using a harvesting and grafting process that has been designed by Momelan Technologies. The overall concept is to harvest several small pieces of skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a commercially available suction blister device, adhere them to a sterile elastomeric substrate and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).

NCT ID: NCT01259986 Terminated - Vitiligo Clinical Trials

Treatment of Vitiligo With Low-energy Visible Light Laser

Start date: October 2010
Phase: N/A
Study type: Interventional

The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible light laser in the treatment of various recalcitrant forms of vitiligo.

NCT ID: NCT00771355 Terminated - Vitiligo Clinical Trials

In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

Start date: August 2008
Phase: N/A
Study type: Observational

This is a pilot study to evaluate the findings of the Reflectance Confocal Microscopy when performed in cutaneous pigmentary disorders, such as vitiligo, melasma, post-inflammatory hyper-pigmentation and hypo-pigmentation. Confocal Microscopy is a recent diagnostic technique that has been used for observation of skin conditions that affect the superficial layers of the skin.

NCT ID: NCT00177034 Terminated - Vitiligo Clinical Trials

Examination Of Vitiligo Skin Samples Before and After UVB Treatment

Start date: November 2004
Phase: N/A
Study type: Interventional

The keratinocytes of lesional skin of vitiligo compared to normal and perilesional skin will differentially express genes correlating with melanocyte death. Narrow Band UVB should then hopefully reverse the pattern of gene expression back toward normal.