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Vitiligo clinical trials

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NCT ID: NCT03367273 Completed - Vitiligo Clinical Trials

Thymic Stromal Lymphopoietin (TSLP) in Vitiligo

Start date: January 2017
Phase: N/A
Study type: Interventional

study & verify the hypothesis of the involvement of TSLP in the pathogenesis of vitiligo in comparison to their levels in the healthy control persons.

NCT ID: NCT03323125 Completed - Vitiligo Clinical Trials

Photoprotection Habits in Patients With Vitiligo

VITISUN
Start date: October 16, 2017
Phase:
Study type: Observational

Intro: Patients with vitiligo have a reduced protection on depigmented areas. To date, however, little is known about photoprotection habits in patients with vitiligo even though these patients are thought to have a decreased ability to efficiently protect their skin against sun damage. Moreover, exposure to artificial UV is one of the major elements of the treatment of vitiligo even though certain phenotypes of vitiligo could be photoinduced. Hypothesis The Primary objective is to describe patients behaviour with sun exposition The Secondary objectives are: - to assess the link between sun exposition and vitiligo outbreaks - to assess photoprotection habits according to initial phototype and vitiligo severity (SA-VES) - To validate a short form of the VIPs questionnaire, a validated burden questionnaire. Method We aim to conduct a prospective cross sectional study in patients with Vitiligo with the aim to evaluate sun protection habits in patients with vitiligo. For that purpose a semi-directed questionnaire to investigate the sun protection behavior of vitiligo patients (adults> 18 years of age) have been created by experts in the field. Vitiligo severity will be self-assessed by patients using a recently validated patient reported outcome, the SA-VES. Consecutive vitiligo patients consulting in the dermatology department of Henri Mondor Hospital (Créteil, France) will be proposed to participate the study after having given their oral consent. We are planning to enrol 500 patients. In a first step, a descriptive analysis will be carried out in order to describe the characteristics of the sample. Basic summary statistics, such as proportions, means and standard deviations, will be used to characterize the population. In order to identify the factors associated with the severity of the disease on the one hand and the phototype on the other, comparisons between groups (severe versus non-severe and light phototype versus dark phototype) will be carried out by unconditional logistic regression. All potential predictors of severity will first be assessed individually, and Odds Ratio (OR), corresponding 95% CIs and P values will be calculated. The significance of the OR will be determined by the Wald test χ2, and the predictors with P <.20 will then be evaluated using a multivariate analysis with a pre-selection procedure. Possible interactions and multi-colinearity will be examined. Finally, the quality of fit of the final model will be evaluated using the logistic regression diagnostic procedure. P ≤ 0.05 will be considered as statistically significant. The Hosmer-Lemeshow test will be carried out to test the suitability of the model. Conclusion This study will help to identify gaps in the knowledge of sun protection habits in patients with vitiligo.

NCT ID: NCT03270241 Completed - Vitiligo Clinical Trials

Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients' quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has been shown to promote repigmentation and normalize cellular behaviors. The investigators would like to analyze the change in protein expression and histological change in skin from NB-UVB treatment in participants with Vitiligo. The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.

NCT ID: NCT03249064 Completed - VITILIGO Clinical Trials

Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo

Start date: October 27, 2015
Phase: N/A
Study type: Observational

This study aims to evaluate some differences in the immune system between patients with vitiligo and patients without the disease. These differences will be evaluated by the extraction of peripheral blood that will be analyzed before the treatment and after the treatment that, in the habitual way and at the discretion of the responsible dermatologist. Patients agreeing to participate in the study will be subjected to extraction of two tubes (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment. Therefore, neither treatment nor follow-up visits will be modified by participation, but will be the same whether or not participate in the study. In the case of controls, two peripheral blood tubes (20ml) will be removed in a single participation. Patients with vitiligo will also be asked to complete questionnaires to measure stress, depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12 weeks (+/- 5 days) of therapeutic intervention . This study will include 20 patients with active non-segmental vitiligo and 10 controls without the disease. The duration of participation in this study will be 12 weeks (+/- 5 days) for patients with vitiligo and a single participation (extraction of 20 ml of peripheral venous blood) for the controls.

NCT ID: NCT03247400 Completed - Clinical trials for Non-segmental Vitiligo

The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo

EVRAAS
Start date: December 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with non-segmental vitiligo.

NCT ID: NCT03133871 Completed - Vitiligo Clinical Trials

Evaluation of Scanoskin for the Assessment of Vitiligo

Start date: March 1, 2017
Phase:
Study type: Observational

The aim of this study is to establish whether the use of a special digital camera (SIAscopy) can provide an accurate and reliable measure of vitiligo which is at least equivalent to the current gold standard of planimetry. If so, SIAscopy could be used as an objective diagnostic and prognostic tool in the management of vitiligo patients within dermatology departments and allow a fair and accurate assessment of new potential treatments.

NCT ID: NCT03123016 Completed - Vitiligo Clinical Trials

Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo

Start date: April 14, 2017
Phase: Phase 2
Study type: Interventional

Vitiligo is a common acquired disorder of pigmentation affecting 0.5% to 1% of the world population. Sharply demarcated patches of depigmentation, which can affect all ethnicities, and can lead to cosmetic disfiguration and psychosocial distress, characterize the disease. The etiology of vitiligo remains unknown. Various mechanisms have been proposed, such as autoimmunity, self-destruction, biochemical, genetic, neural, oxidative stress, and an imbalance of epidermal cytokines leading to inflammation and selective loss of epidermal melanocytes. Currently, the most popular theory is autoimmunity. Previous studies noted that around 25-30% of patients have at least one other autoimmune disease, such as autoimmune thyroid disease, Addison's disease, pernicious anemia, and alopecia areata. Currently, NB-UVB phototherapy is the most widely used therapeutic option for vitiligo affecting more than 10-20% of the skin surface, as it is generally considered to be a safe initial treatment. Potential side effects include phototoxic reaction, thickening of the skin and koebnerization. NB-UVB is a band of UV radiation with a wavelength of 311-313 nm. UVB induces mitogenesis and migration in melanocytes mediated by several factors such as IL-1, TNF alpha, and leukotriene C4. UV radiation produces increased number and activity of melanocytes, increased melanin density, elongation and branching of dendrites, with increased transfer of more heavily melanized melanosomes to keratinocytes, seen clinically as increased pigmentation. Apremilast is an oral small molecule phosphodiesterase-4 (PDE4) inhibitor that has been shown to regulate inflammatory mediators. Apremilast enters cells by passive diffusion and, once intracellular, binds PDE4. PDE-4, the dominant phosphodiesterase expressed in immune cells, degrades cyclic AMP (cAMP) into AMP. PDE4 inhibition thereby elevates intracellular cAMP, which can down-regulate the inflammatory responses such as TNF-α, IFN-γ, interleukins (IL) 2, 12 and 23 through mechanisms such as partially inhibiting expression of inflammatory cytokines and increasing expression of anti-inflammatory mediators such as IL2 and IL10. The hypothesis is that apremilast will shut down the inflammatory insult in vitiligo and NB-UVB phototherapy will then be able to regenerate melanocytes and their activity. By examination of skin biopsies taken pre- and post-therapy, the study team aims to assess changes in immune and cellular markers in affected skin.

NCT ID: NCT03099304 Completed - Vitiligo Clinical Trials

A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Start date: June 7, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.

NCT ID: NCT03047733 Completed - Vitiligo Clinical Trials

Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo

Start date: July 21, 2015
Phase: N/A
Study type: Interventional

OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the conventional continuous excimer laser treatment. DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was performed in two tertiary health care centers in Korea. PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than 5 years' disease duration were enrolled. INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic on-off treatment. All lesions were treated twice weekly for 9-month: continuously, or cyclically with 2-month treatment and 1-month intermission (total 3 cycles). Topical tacrolimus was applied throughout the trial. OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with clinical photographs. The primary outcome was mean difference of repigmentation rates and the non-inferiority margin was set at 10%. During intermission period, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.

NCT ID: NCT03036995 Completed - Vitiligo Clinical Trials

Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO

Rapid Vitiligo
Start date: March 20, 2017
Phase: Phase 2
Study type: Interventional

Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an acquired pigmentary disorder of the skin and mucous membranes that is characterized by circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4) inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and psoriasis. Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading to anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes. Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for promoting melanogenesis and for inducing the differentiation and the proliferation of melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo. Patients with non-segmental vitiligo with BSA > 10% and patient with Vitiligo stable or slowly progressive for 3 months , seeking for treatment in the Department of Dermatology, University Hospital of Nice, France will be recruited into the study. The Patients are seen in consultation by the investigator, selection criteria are checked. All patients will receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks. From W24 to W48 - All responders* will receive narrow UVB treatment according the French clinical use i.e.twice weekly sessions of narrowband UVB for 24 weeks. - All responders* will be randomized to receive either apremilast** 30mg BID or placebo. - Response is defined as an increase of at least 30 % in the VASI score at W24 compare to baseline **Responders initially randomized in the placebo arm will benefit of the titration At week 24, the non responders patients will stop the treatment and the study after the 4 weeks observationnal follow-up (W28). Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all subjects who complete the study (responders and non responders) or discontinue the study early.