Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix - Full Text View

Sponsor:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00129428

Purpose

This research study will evaluate the effectiveness of high dose UVB light therapy in the treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare or related conditions.

Condition	Intervention	Phase
Keloid Scleroderma, Localized Acne Keloidalis Scars Granuloma Annulare	Procedure: UVB Irradiation	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Effectiveness of UVB Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Acne Burns Scars Scleroderma Skin Conditions

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Improvement in appearance of keloids (hypertrophic scars), scleroderma, acne keloidalis nuchae,old burn scars, granuloma annulare, and related conditions with altered dermal matrix [ Time Frame: Subjects will be evaluated at weeks 1, 2, 4, and then at monthly intervals until the end of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assays to be performed on biopsy specimens may include any or all of the following assays: in situ hybridization, immunohistologic analysis, in situ zymography, radioimmunoassay, and Western blot analysis [ Time Frame: Assays will be performed after specimen collection ] [ Designated as safety issue: No ]
Photographs will also be taken. [ Time Frame: At baseline and at end of the study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2002
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.

Detailed Description:

Keloid, scleroderma, acne keloidalis nuchae, and burn scars are all characterized by collagenous thickening of the skin resulting in superficial and deep cutaneous sclerosis. Treatments for these disabling conditions are inadequate at present. Recently, in non-controlled studies, UVA1 was shown to induce improvement in patients with scleroderma, granuloma annulare and urticaria pigmentosa.

However, UVA1 is unable to penetrate pigmented skin at an effective level to activate matrix metalloproteinases (MMPs). The investigators' preliminary data show that high dose UVB (160 mJ/cm2) will penetrate pigmented skin and activate the cellular pathways necessary to stimulate MMPs. They postulate, therefore, that in pigmented skin, higher than usual UVB doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen via activation of MMP pathways.

The purpose of this research project is to study the effectiveness of high dose UVB (290-320nm at up to 320mJ/cm2) irradiation for the treatment of skin conditions with altered dermal matrix in patients with increased skin pigmentation. These disorders include but are not limited to keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, and granuloma annulare. Up to fifty patients with one of these diagnoses or related conditions will receive UVB irradiation up to 5 times per week, for 16 weeks.

Eligibility

Ages Eligible for Study:	10 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In good general health and between 10-80 years of age.
Willing and able to receive UVB, as directed in the protocol; make evaluation visits; follow protocol restrictions; and sign a written, witnessed, informed consent form.
Have a clinical diagnosis of keloid, scleroderma, old burn scars, granuloma annulare, or acne keloidalis nuchae.
No disease states or physical conditions that would impair evaluation of the test site
Must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

Have a history of photosensitivity (development of hives or bumps with exposure to light) or experience hypersensitivity in a UVB photo-provocation test.
Have participated in another investigational study in the past 4 weeks, taken oral therapy for skin condition, or on photosensitizing medications.
Pregnant, nursing, or planning to become pregnant during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129428

Locations

United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

Study Chair:

John J Voorhees, MD

University of Michigan

More Information

No publications provided

Responsible Party:	University of Michigan Department of Dermatology ( Sewon Kang, MD, Professor and Director of Clinical Pharmacology )
Study ID Numbers:	Derm 447
Study First Received:	August 9, 2005
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00129428 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

UVB
keloid
scleroderma

acne keloidalis nuchae
scars
granuloma annulare

Additional relevant MeSH terms:

Hair Diseases
Facial Dermatoses
Skin Diseases
Collagen Diseases
Keloid
Acne Keloid
Granuloma
Lymphatic Diseases
Pathologic Processes

Acneiform Eruptions
Necrobiotic Disorders
Connective Tissue Diseases
Lymphoproliferative Disorders
Scleroderma, Localized
Granuloma Annulare
Folliculitis
Cicatrix

ClinicalTrials.gov processed this record on November 22, 2009