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

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

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.

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00129428

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

Study chairs or principal investigators

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

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