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

Assiut University

Status and phase: Unknown; Phase 1

Conditions: Vitiligo Vulgaris

Treatments: Drug: NB-UVB; Drug: calcipotriol ointment; Drug: Tacrolimus ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT03234673

TEOPFCLEWTCOWNITTOSGV

Details and patient eligibility

About

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).

Full 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)

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Group A (Tacrolimus group):

Experimental group

Description:

fractional CO2 laser therapy and Tacrolimus ointment 1

Treatment:

Drug: Tacrolimus ointment

Group B (Calcipotriol group):

Experimental group

Description:

fractional CO2 laser therapy and Calcipotriol ointment

Treatment:

Drug: calcipotriol ointment

Group C (NB-UVB group):

Experimental group

Description:

fractional CO2 laser therapy and NB-UVB twice weekly

Treatment:

Drug: NB-UVB