NB-UVB and PUVA Vitiligo Study

This study is currently recruiting participants.
Verified March 2013 by Henry Ford Health System
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01732965
First received: November 13, 2012
Last updated: March 27, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Henry Ford Health System:

Primary Outcome Measures:
  • Determine the quantity of repigmentation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: March 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vitiligo affecting more than 15% body surface area.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732965

Contacts
Contact: Prescilia Isedeh, MD 313-916-6964 pisedeh1@hfhs.org
Contact: Virginia Reeder, MD 313-916-6964 vreeder1@hfhs.org

Locations
United States, Michigan
Henry Ford Dermatology Recruiting
Detroit, Michigan, United States, 48202
Contact: Prescilia Isedeh, MD    313-916-6964    pisedeh1@hfhs.org   
Principal Investigator: Iltefat Hamzavi, MD         
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat Hamzavi, MD Henry Ford Dermatology
  More Information

No publications provided

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
Study First Received: November 13, 2012
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Henry Ford Health System:
Vitiligo
Phototherapy
Photochemotherapy

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014