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NB-UVB and PUVA Vitiligo Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732965
First Posted: November 26, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
  Purpose
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.

Condition Intervention Phase
Vitiligo Other: Phototherapy Other: Phototherapy and Photochemotherapy Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Iltefat Hamzavi, Henry Ford Health System:

Primary Outcome Measures:
  • Determine the quantity of repigmentation [ Time Frame: 6 months ]
    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. [ Time Frame: Study initiation, 3 months and 6 months. ]
    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.


Enrollment: 10
Study Start Date: March 2013
Study Completion Date: May 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: NB-UVB phototherapy
NB-UVB alone
Other: Phototherapy
Experimental: phototherapy and photochemotherapy
NB-UVB and PUVA
Other: Phototherapy and Photochemotherapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vitiligo affecting more than 15% body surface area.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732965


Locations
United States, Michigan
Henry Ford Dermatology
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat Hamzavi, MD Henry Ford Dermatology
  More Information

Responsible Party: Iltefat Hamzavi, Senior Staff Physician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01732965     History of Changes
Other Study ID Numbers: HFHS Vitiligo Phototherapy
First Submitted: November 13, 2012
First Posted: November 26, 2012
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Iltefat Hamzavi, Henry Ford Health System:
Vitiligo
Phototherapy
Photochemotherapy

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases