Comparing the Efficacy of Visible Light-Ultraviolet A1 Light Versus Narrowband-Ultraviolet B on Generalized Vitiligo

Generalized Vitiligo Clinical Trial

Official title:

Comparing the Efficacy of VL-UVA1 Versus NB-UVB on Inducing Repigmentation in Subjects With Generalized Vitiligo

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05238077
• Other study ID #: 11973
• Status: Terminated
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: June 2, 2020

Study information

• Verified date: February 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As part of this study, you may have a procedure called phototherapy which involves either VL-UVA or NB-UVB irradiation. NB-UVB phototherapy is not experimental in vitiligo, but use of VL-UVA1 phototherapy in vitiligo is.

The purpose of this pilot study is to determine whether VL-UVA1 or NB-UVB phototherapy more efficiently induces repigmentation in patients with generalized vitiligo.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects = 18 years of age with a diagnosis of generalized vitiligo

• Subjects on a stable topical/oral regimen for the past 3 months and continuing on a stable regimen

• Subjects able to understand the requirements of the study

• Subjects able and willing to sign informed consent

Exclusion Criteria:

• Subjects on photosensitizing medications

• Subjects receiving any concurrent phototherapy

• Subjects who plan to use tanning parlors or expose themselves to excess sunlight

• Subjects with known photosensitivity disorder

• Subjects with apparent phototoxicity

• Subjects with unstable vitiligo

• Subjects currently using bleaching agents

• Subjects who are pregnant, lactating, or planning on becoming pregnant

• Subjects who in the opinion of the investigator/sub-investigator, are not appropriate candidates for this study

Related Conditions & MeSH terms

• Generalized Vitiligo
• Vitiligo

Intervention

Procedure:
• Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy
Patients will have different kinds of light shined on different areas

Locations

Country	Name	City	State
United States	Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depigmentation of vitiligo lesion	Change in pigment will be assessed by colorimetry which measures change in pigment	13 measurements over 26 visits
Primary	Change in melanin content of vitiligo lesion	Change in pigment will be assessed by diffuse reflectance spectroscopy which will measure the melanin content and dyschromia	13 measurements over 26 visits