Back to resultsNB-UVB and PUVA Vitiligo Study
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Phototherapy
Phototherapy and Photochemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Phototherapy, Photochemotherapy
Eligibility Criteria
Inclusion Criteria:
- Vitiligo affecting more than 15% body surface area.
Sites / Locations
- Henry Ford Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
NB-UVB phototherapy
phototherapy and photochemotherapy
Arm Description
NB-UVB alone
NB-UVB and PUVA
Outcomes
Primary Outcome Measures
Determine the quantity of repigmentation
Determination the degree of repigmentation measured by the VASI score (Vitiligo area Scoring Index) after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
Secondary Outcome Measures
Determine the quality of repigmentation.
Determination of the color of repigmentation, pattern of repigmentation, and the cessation of spread of vitiligo after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
Full Information
NCT ID
NCT01732965
First Posted
November 13, 2012
Last Updated
February 22, 2017
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT01732965
Brief Title
NB-UVB and PUVA Vitiligo Study
Official Title
Prospective Open Parallel Right to Left Bilateral Study Comparing Narrowband Ultraviolet B Alone Versus Narrowband Ultraviolet B and Psoralen Plus Ultraviolet A for the Treatment of Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is more effective than narrowband ultraviolet B alone in the treatment of vitiligo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo, Phototherapy, Photochemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NB-UVB phototherapy
Arm Type
Placebo Comparator
Arm Description
NB-UVB alone
Arm Title
phototherapy and photochemotherapy
Arm Type
Experimental
Arm Description
NB-UVB and PUVA
Intervention Type
Other
Intervention Name(s)
Phototherapy
Intervention Type
Other
Intervention Name(s)
Phototherapy and Photochemotherapy
Primary Outcome Measure Information:
Title
Determine the quantity of repigmentation
Description
Determination the degree of repigmentation measured by the VASI score (Vitiligo area Scoring Index) after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determine the quality of repigmentation.
Description
Determination of the color of repigmentation, pattern of repigmentation, and the cessation of spread of vitiligo after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
Time Frame
Study initiation, 3 months and 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Vitiligo affecting more than 15% body surface area.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat Hamzavi, MD
Organizational Affiliation
Henry Ford Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Dermatology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NB-UVB and PUVA Vitiligo Study
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