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

NCT05238077 | Terminated

• 1 other identifier: 11973
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Vitiligo

Outcome Measures

Primary Outcomes (2)

• Change in depigmentation of vitiligo lesion

  Change in pigment will be assessed by colorimetry which measures change in pigment

  13 measurements over 26 visits

• 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

Study Arms (1)

VL-UVA1 vs NB-UVB

OTHER

Participants will be treated with both VL-UVA and NB-UVB on different areas

Procedure: Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy

Interventions

Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy PROCEDURE

Patients will have different kinds of light shined on different areas

VL-UVA1 vs NB-UVB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,

Detroit, Michigan, 48202, United States

Location

Study Officials

• Iltefat Hamzavi, M.D.

  Henry Ford HS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Investigator Initiated Studies

Model Details: The subject serves as their own control.

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: February 14, 2022
• Study Start: February 26, 2018
• Primary Completion: May 1, 2020
• Study Completion: June 2, 2020
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)