The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo
| Registry | NCT03234673 |
|---|---|
| Status | Unknown |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Vitiligo Vulgaris |
| Interventions | Tacrolimus ointment, calcipotriol ointment, NB-UVB (Drug) |
| Dates | start 2017-08-01 (estimated), primary completion 2018-08-01 (estimated), completion 2019-01-01 (estimated), first posted 2017-07-31, last updated 2017-08-01 |
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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).
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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A (Tacrolimus group): | Experimental | Drug: Tacrolimus ointment | fractional CO2 laser therapy and Tacrolimus ointment 1 |
| Group B (Calcipotriol group): | Experimental | Drug: calcipotriol ointment | fractional CO2 laser therapy and Calcipotriol ointment |
| Group C (NB-UVB group): | Experimental | Drug: NB-UVB | fractional CO2 laser therapy and NB-UVB twice weekly |
Sex: All, ages: 12 Years to 60 Years
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.