Narrowband UVB Treatment in Patients With Vitiligo

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398723
• Other study ID #: RUH IRB # JCO 0590
• Status: Completed
• Phase: N/A
• First received: November 10, 2006
• Last updated: October 11, 2011
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: October 2011
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Device:
• Narrowband UVB
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

Locations

Country	Name	City	State
United States	Rockefeller University Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mary Sullivan-Whalen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of melanocytes per unit length of skin surface		pre-treatment, early repigmentation, 75% repigmentation of total body	No
Secondary	Clinical improvement		first visit and last visit	No