Fractional Laser in Combination With UVB Therapy in Vitiligo Patients

Study Overview
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Brief Summary
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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.

Official Title
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Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.

Conditions
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Vitiligo

Intervention / Treatment
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* Device: Fractional CO2 laser
* Other: NB-UVB therapy
* Drug: Fluticasone Propionate Cream 0.05%


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients with non segmental (generalised) vitiligo visiting the Netherlands Institute for Pigment Disorders receiving NB- UVB treatment for 3 to 6 months Age >18 years At least 3 therapy resistant vitiligo lesions on the extremities or trunk larger than 5x5 cm or one vitiligo lesion on the extremities or trunk of at least 5x15 cm. Patient is willing and able to give written informed consent Exclusion criteria Skin type I Recurrent HSV skin infections Hypertrophic scars Keloid Cardial insufficiency Patients who are pregnant or breast-feeding Patients not competent to understand what the procedures involved Patients with a personal history of melanoma or non-melanoma skin cancer Patients with atypical nevi.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser+fluticason+UVB<br>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. | Device: Fractional CO2 laser<br> <br> Other: NB-UVB therapy<br>* NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.<br>Drug: Fluticasone Propionate Cream 0.05%<br>* 4 times a week (standard IPD protocol)<br>|
| Experimental: Laser+UVB<br>In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). | Device: Fractional CO2 laser<br> <br> Other: NB-UVB therapy<br>* NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.<br>|
| Active Comparator: UVB<br>As control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2. | Other: NB-UVB therapy<br>* NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repigmentation % with sheets | % of repigmentation | 6 mo after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultraviolet therapy, non segmental, vitiligo, topical corticosteroid, laser, fractional, CO2, carbon dioxide, UVB