Fractional laser abrasion in combination with UVB therapy in vitiligo patients: a randomized controlled study

Fractional laser abrasion in combination with UVB therapy in vitiligo patients: a randomized controlled study - Fractional laser in combination with UVB therapy in vitiligo patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40502

Enrollment

Registered

2014-07-18

Start date

2015-09-30

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leukoderma

Interventions

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. N

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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
Main study parameter/endpoint: Objective assessment of the degree of repigmentation 6 months after the first fractional laser therapy. Assessment will be done on sheets, using a digital image analysis system. Software based on Matlab will be used to analyse the images and to calculate the depigmented surface. By comparing pre- and post treatment images, the surface showing repigmentation can be computed.	—

Measure

Time frame

Main study parameter/endpoint: Objective assessment of the degree of repigmentation 6 months after the first fractional laser therapy. Assessment will be done on sheets, using a digital image analysis system. Software based on Matlab will be used to analyse the images and to calculate the depigmented surface. By comparing pre- and post treatment images, the surface showing repigmentation can be computed.

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Secondary

Measure	Time frame
Secondary study parameters/endpoints: - Visual assessment of side effects per treatment region (hyperpigmentation, hypo- pigmentation and scar formation on a scale from 0-3) will be done by a blinded investigator. - General outcome will be assessed by the patient and physician per treatment region on a scale from 0-3 - Colour difference i.e. the difference between erythema and pigmentation will be assessed with a Derma-spectrometer	—

Measure

Time frame

Secondary study parameters/endpoints: - Visual assessment of side effects per treatment region (hyperpigmentation, hypo- pigmentation and scar formation on a scale from 0-3) will be done by a blinded investigator. - General outcome will be assessed by the patient and physician per treatment region on a scale from 0-3 - Colour difference i.e. the difference between erythema and pigmentation will be assessed with a Derma-spectrometer

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)