A Phase 1/2 interventional study of UVB Irradiation in Keloid, Scleroderma, Localized and Acne Keloidalis, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-01.
Sponsored by University of Michigan · Phase 1/2, Interventional, and Prevention
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.
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.
124 studies on the registry are indexed under Keloid; 23 are open to participants now.
This study's enrollment of 33 is close to the median of 30 across 98 interventional studies indexed under Keloid.
Browse Keloid studies →University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
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Exclusion Criteria:
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.
Procedure: UVB Irradiation
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.
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.
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
Photographs will also be taken.
Time frame: At baseline and at end of the study.
The record gives a start of Aug 2002, a primary completion of Jan 2009 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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