Clinical trial NCT02290717: Fractional Laser in Combination With UVB Therapy in Vitiligo Patients
Official title: Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vitiligo
Keywords: ultraviolet therapy
non segmental
vitiligo
topical corticosteroid
laser
fractional
CO2
carbon dioxide
UVB
Lead sponsor: Netherlands Institute for Pigment Disorders
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Repigmentation % with sheets
timeFrame: 6 mo after treatment
Secondary outcomes:
measure: Global assessment physician
timeFrame: 6 months after treatment
measure: Global assessment patient
timeFrame: 6 months after treatment
measure: Visual assessment of hyperpigmentation/hypopigmentation/scar formation
timeFrame: 6 months after treatment
measure: Global assessment of repigmentation physician
timeFrame: 6months after treatment
Other outcomes:
measure: Adverse events
timeFrame: 6 months after treatment
measure: Color difference between erythema and (re)pigmentation
timeFrame: 6 months after treatment
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
Study officials:
References:
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