NB-UVB and PUVA Vitiligo Study

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014