View clinical trials related to Pigmentation Disorders.
Filter by: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.
We have added objectives 4-6 to our updated study: Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient. Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify "signature" lesions. Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity. Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics. Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion. Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.
This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients with hypo pigmented skin or surgical skin wounds.
This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).
The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.
The purpose of this study is to determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus.
The purpose of this research is to develop non-invasive imaging modalities for assessment of skin. This is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. The researchers understand that the purpose of this study is not to evaluate any particular treatment and an investigation of a new therapeutic intervention would require an additional protocol. Skin conditions to be studied include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.
The incidence of malignant melanoma has increased dramatically in recent decades. In 1930, the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500. This has been exponentially increasing over the years with the risk estimated to be 1 in 75 in 2000 . According to the American Cancer Society, approximately 59,580 new cases of melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected to die of the disease.
The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.