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

Not Applicable

Terminated

• Conditions: Generalized Vitiligo
• Interventions: Procedure: Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy

• Registration Number: NCT05238077
• Lead Sponsor: Henry Ford Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-26
• Study First Submitted: 2019-07-22
• Primary Completion: 2020-05-01
• Study Completion: 2020-06-02
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-14
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VL-UVA1 vs NB-UVB	Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy	Participants will be treated with both VL-UVA and NB-UVB on different areas

Primary Outcome Measures

Name	Time	Method
Change in melanin content of vitiligo lesion	13 measurements over 26 visits	Change in pigment will be assessed by diffuse reflectance spectroscopy which will measure the melanin content and dyschromia
Change in depigmentation of vitiligo lesion	13 measurements over 26 visits	Change in pigment will be assessed by colorimetry which measures change in pigment

Trial Locations

Locations (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,; 🇺🇸 Detroit, Michigan, United States