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OpenTrials
Completed

NCT Number: NCT00398723

Narrowband UVB Treatment in Patients With Vitiligo

The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo.

The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rockefeller University Hospital

New York, 10021, United States

About this study

All patients will receive phototherapy, with narrowband UVB, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) will be analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years of age or greater
  • Vitiligo with extensive skin involvement (>5% body surface affected).

Exclusion criteria

  • No treatment with topical steroids, calcineurin inhibitors or vitamin D analogs for at least 4 weeks prior to entering the study.
  • No treatment with systemic therapies, including methotrexate, etretinate, PUVA, or cyclosporine 4 weeks prior to entering the study.

Treatment and study plan

Narrowband UVB

Device

Treatment three to seven times weekly for a total of 12 to 26 weeks (36 to 168 treatments). Dosing of NB-UVB will begin at 100-280 mJ/cm2, depending on tolerance and skin type, and will be titrated 10-20% per session until clinical efficacy or symptomatic erythema

Primary outcomes

  1. Number of melanocytes per unit length of skin surface

    Time frame: pre-treatment, early repigmentation, 75% repigmentation of total body

Secondary outcomes

  1. Clinical improvement

    Time frame: first visit and last visit

Sponsors and collaborators

Lead sponsor

Mary Sullivan-Whalen

Other

Registry information

Official study title

Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 14, 2006
Registry last updated
Oct 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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