Vitiligo
Conditions
Keywords
ultraviolet therapy, non segmental, vitiligo, topical corticosteroid, laser, fractional, CO2, carbon dioxide, UVB
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.
Interventions
DEVICEFractional CO2 laser
OTHERNB-UVB therapy
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.
4 times a week (standard IPD protocol)
Sponsors
Netherlands Institute for Pigment Disorders
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repigmentation % with sheets | 6 mo after treatment | % of repigmentation |
Secondary
| Measure | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 6 months after treatment | — |
| Color difference between erythema and (re)pigmentation | 6 months after treatment | with a Derma-spectrometer the difference between erythema and (re)pigmentation will be assessed. |
Countries
Netherlands
Outcome results
None listed