The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo

Study Overview
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Brief Summary
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Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009). Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).

Detailed Description
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Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013). Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)

Official Title
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The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo

Conditions
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Vitiligo Vulgaris

Intervention / Treatment
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* Drug: Tacrolimus ointment
* Drug: calcipotriol ointment
* Drug: NB-UVB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with stable vitiligo nonsegmental vitiligo will be recruited A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year Exclusion Criteria: Patients with active infection. Reported histories of koebnerization. History of keloid formation or hypertrophic scars. Pregnant or lactating females. Bleeding tendency.

Ages Eligible for Study
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Minimum Age: 12 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 |
| --- | --- |
| Experimental: Group A (Tacrolimus group):<br>fractional CO2 laser therapy and Tacrolimus ointment 1 | Drug: Tacrolimus ointment<br>* 3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.<br>* Other names: tarolimus ointment;|
| Experimental: Group B (Calcipotriol group):<br>fractional CO2 laser therapy and Calcipotriol ointment | Drug: calcipotriol ointment<br>* 3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.<br>* Other names: calcipoheal;|
| Experimental: Group C (NB-UVB group):<br>fractional CO2 laser therapy and NB-UVB twice weekly | Drug: NB-UVB<br>* 3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months<br>* Other names: narrow band ultraviolet rays B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016). | G0, < 25% repigmentation (poor) G1, 25-50% repigmentation (fair) G2, 50-75% repigmentation (good) G3 > 75% repigmentation (excellent). | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The VASI percent change | The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score. | every month for 3 months |