Fractional Laser in Combination With UVB Therapy in Vitiligo Patients
- Conditions
- Vitiligo
- Interventions
- Registration Number
- NCT02290717
- Lead Sponsor
- Netherlands Institute for Pigment Disorders
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laser+fluticason+UVB NB-UVB therapy The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study. Laser+UVB NB-UVB therapy In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). Laser+fluticason+UVB Fluticasone Propionate Cream 0.05% The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study. Laser+UVB Fractional CO2 laser In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). UVB NB-UVB therapy As control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2. Laser+fluticason+UVB Fractional CO2 laser The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study.
- Primary Outcome Measures
Name Time Method Repigmentation % with sheets 6 mo after treatment % of repigmentation
- Secondary Outcome Measures
Name Time Method Global assessment physician 6 months after treatment Global assessment patient 6 months after treatment Visual assessment of hyperpigmentation/hypopigmentation/scar formation 6 months after treatment Global assessment of repigmentation physician 6months after treatment
Trial Locations
- Locations (1)
Academic Medical Centre
🇳🇱Amsterdam, Netherlands