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

History of Changes

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:

Genetics Home Reference related topics: vitiligo

MedlinePlus related topics: Vitiligo

U.S. FDA Resources

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 June 17, 2013

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