Vitiligo Clinical Trial
Official title:
Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.
Rationale: Vitiligo is a common skin disorder that can impair a patient's quality of life.
Many depigmented lesions in vitiligo patients remain therapy resistant for medical
treatment. Therefore new therapeutic options in these patients are necessary. Currently,
dermabrasion by conventional or fractional laser therapy in combination with NB-UVB therapy
and steroids appears to be effective in therapy resistant areas. However, little literature
on this combination is available.
Objectives: To assess the efficacy and patient safety of (1)fractional CO2-laser treatment
in combination with NB- UVB,(2) fractional CO2-laser treatment in combination with NB- UVB
and topical corticosteroids versus NB-UVB treatment alone(3) Study design: Prospective
observer blinded randomised intra-patient controlled study.
Study population: 23 patients ≥ 18 years with non segmental vitiligo who receive NB-UVB
treatment at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical
Centre University of Amsterdam. We will include patients with 3 depigmented lesions that are
resistant to NB- UVB treatment after 3 to 6 months.
Methods: Three NB-UVB resistant depigmented regions on the trunk or extremities will be
randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2 laser
abrasion, or (2) NB-UVB treatment in combination with fractional CO2 laser abrasion and
topical steroids, or (3) NB-UVB treatment alone. NB-UVB treatment and topical steroids will
be given according to the standard treatment protocol of the SNIP and continued for at least
6 months. Two and 6 months after the laser treatment, the percentage of repigmentation of
the lesions will be assessed.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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