Clinical Trial: The Effectiveness of UVB Light Therapy in the Treatment of Skin Conditions with Altered Dermal Matrix

This study is currently recruiting patients.
Verified by University of Michigan August 2005

Sponsored by: 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 in subjects with darkly pigmented skin.
Condition Intervention Phase
Keloid
Scleroderma
Acne Keloidalis Nuchae
Scars
Granuloma Annulare
 Procedure: UVB Irradiation
Phase II
Phase III

MedlinePlus related topics:  Connective Tissue Disorders;   Scars;   Scleroderma;   Skin Conditions

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

Further Study Details: 
Primary Outcomes: Improvement in appearance of keloids (hypertrophic scars), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare, and related conditions with altered dermal matrix.
Secondary Outcomes: 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.; Photographs will also be taken.
Expected Total Enrollment:  50

Study start: August 2002;  Expected completion: March 2008
Last follow-up: August 2007;  Data entry closure: October 2007

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). Our preliminary data shows that high dose UVB (160 mJ/cm2) will penetrate pigmented skin and activate the cellular pathways necessary to stimulate MMPs. We 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, with skin type III or greater, will receive UVB irradiation up to 5 times per week, for 16 weeks.

Eligibility

Ages Eligible for Study:  10 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

•Be in good general health and between 10-80 years of age. •Medium to dark skin tone •Be 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

Exclusion Criteria:

•Have a history of photosensitivity (development of hives or bumps with exposure to light) or experience hypersensitivity in an UVB photo-provocation test.

•Have participated in another investigational study in the past 4 weeks, taken oral therapy for your skin condition, or on photosensitizing medications.

•Participate if you are pregnant, or nursing, or planning to become pregnant during the study.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00129428


Michigan
      University of Michigan Department of Dermatology, Ann Arbor,  Michigan,  48109,  United States; Recruiting
Martha E Boggs  734-936-4058    haabme@umich.edu 
Sewon Kang, MD  734-936-4192    swkang@umich.edu 
Sewon Kang, MD,  Principal Investigator

Study chairs or principal investigators

John J Voorhees, MD,  Study Chair,  University of Michigan   

More Information

Study ID Numbers:  Derm 447
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129428
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23

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