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

Phase 1

• Conditions: Vitiligo Vulgaris
• Interventions: Drug: Tacrolimus ointment; Drug: calcipotriol ointment; Drug: NB-UVB

• Registration Number: NCT03234673
• Lead Sponsor: Assiut University

Brief Summary

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

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)

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-28
• Last Update Submitted: 2017-07-30
• Study First Posted: 2017-07-31
• Study Start: 2017-08
• Last Update Posted: 2017-08-01
• Primary Completion: 2018-08
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

1. Patients with active infection.
2. Reported histories of koebnerization.
3. History of keloid formation or hypertrophic scars.
4. Pregnant or lactating females.
5. Bleeding tendency.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Tacrolimus group):	Tacrolimus ointment	fractional CO2 laser therapy and Tacrolimus ointment 1
Group B (Calcipotriol group):	calcipotriol ointment	fractional CO2 laser therapy and Calcipotriol ointment
Group C (NB-UVB group):	NB-UVB	fractional CO2 laser therapy and NB-UVB twice weekly

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The VASI percent change	every month for 3 months	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.