Comparitive Study Between Uvb Alone and Uvb With Topical Tacrolimus 0.03% for the Treatment of Vitiligo

Study Overview
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Brief Summary
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Vitiligo is a skin disorder that causes substantial social and psychological distress due to multiple patches of depigmentation.Disease can target at any age, but it appears to affect various parts of body due to loss of melanin. Although the exact cause of the disease is unknown, several theories suggest that genetic predisposition, autoimmunity, and increased vulnerability of melanocytes to the deleterious effects of harmful metabolites all play a role in disease causation. It impacts 0.1%-2% of the general population, with a 30% familial prevalence rate. Vitiligo treatment still presents a therapeutic challenge for dermatologists despite a variety of therapeutic modalities. Topical steroids, ultraviolet B phototherapy (UVB 280nm-320nm), and photochemotherapy (PUVA i.e., psoralen plus UVA 329nm-400nm) are traditional treatment options. Topical calcipotriol and excimer laser are also used. According to research, narrowband UVB (NB-UVB) is effective when used alone. Few studies, however also, have reported more than 75% re-pigmentation in patients treated with NB-UVB in conjunction with other modalities. Topical immunomodulators (tacrolimus, pimecrolimus) are considered safe and effective long-term treatments for vitiligo because they do not cause skin atrophy, which is associated with long-term use of topical corticosteroids. Tacrolimus is an effective treatment for vitiligo when used alone; in one study, 61% of patients showed more than 75% repigmentation when treated with tacrolimus alone. Another study found that when tacrolimus was combined with NB-UVB, 73% of patients experienced more than 50% repigmentation. The objective of this research was to present a comparatively new mode of treatment that may be beneficial to vitiligo patients.

Official Title
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Comparitive Study Between Uvb Phototherapy Alone and Uvb Photothearpy With Topical 0.03% Tacrolimus for Treatment of Vitiligo

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients having 20-60 years of age non pregnant no history of photosensitivity no history of immunosuppression or immunosuppressive drugs no histry of steroids use oral or topical in last four weeks Exclusion Criteria: pregnancy lactation history of photosensitivity photo-aggravated dermatoses history of any immunosuppressive disorder or use of immunosuppressive medicine history of using steroids either oral or injectable within the previous one month history of skin malignancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A topical tacrolimus 0.03% with uvb phototherapy<br>Group A :contain 30 patients who have been treated with topical 0.03% tacrolimus twice daily at night and then received uvb phototherapy thrice weekly for 12 weeks | Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily<br>* 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily<br>* Other names: ointment eczemus;|
| Active Comparator: Group B topical placebo twice daily with uvb phototherapy thrice weekly<br>Group B :contain 30 patients received uvb phototherapy only thrice weekly for 12 weeks | Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily<br>* 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily<br>* Other names: ointment eczemus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of 0.03% topical tacrolimus with uvb phototherapy and placebo with uvb photothreapy is calculated through repigmentation using a formula {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100} | repigmentation assesed by {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100} | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phototherapy, tacrolimus, vitiligo