Back to resultsComparing the Efficacy of Visible Light-Ultraviolet A1 Light Versus Narrowband-Ultraviolet B on Generalized Vitiligo
Primary Purpose
Generalized Vitiligo
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Vitiligo
Eligibility Criteria
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
Sites / Locations
- Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
VL-UVA1 vs NB-UVB
Arm Description
Participants will be treated with both VL-UVA and NB-UVB on different areas
Outcomes
Primary Outcome Measures
Change in depigmentation of vitiligo lesion
Change in pigment will be assessed by colorimetry which measures change in pigment
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05238077
First Posted
July 22, 2019
Last Updated
February 9, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT05238077
Brief Title
Comparing the Efficacy of Visible Light-Ultraviolet A1 Light Versus Narrowband-Ultraviolet B on Generalized Vitiligo
Official Title
Comparing the Efficacy of VL-UVA1 Versus NB-UVB on Inducing Repigmentation in Subjects With Generalized Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
only one subject enrolled, decided to re-evaluate protocol design
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
June 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The subject serves as their own control.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VL-UVA1 vs NB-UVB
Arm Type
Other
Arm Description
Participants will be treated with both VL-UVA and NB-UVB on different areas
Intervention Type
Procedure
Intervention Name(s)
Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy
Intervention Description
Patients will have different kinds of light shined on different areas
Primary Outcome Measure Information:
Title
Change in depigmentation of vitiligo lesion
Description
Change in pigment will be assessed by colorimetry which measures change in pigment
Time Frame
13 measurements over 26 visits
Title
Change in melanin content of vitiligo lesion
Description
Change in pigment will be assessed by diffuse reflectance spectroscopy which will measure the melanin content and dyschromia
Time Frame
13 measurements over 26 visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat Hamzavi, M.D.
Organizational Affiliation
Henry Ford HS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing the Efficacy of Visible Light-Ultraviolet A1 Light Versus Narrowband-Ultraviolet B on Generalized Vitiligo
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