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Sponsored by: |
University of Michigan |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00129428 |
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 |
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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 |
Estimated Enrollment: | 50 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 10 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
University of Michigan Department of Dermatology | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Kathy Keeley, BS ktkeeley@umich.edu | |
Principal Investigator: Sewon Kang, MD |
Study Chair: | John J Voorhees, MD | University of Michigan |
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: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00129428 |
Health Authority: | United States: Institutional Review Board |
UVB keloid scleroderma |
acne keloidalis nuchae scars granuloma annulare |
Granuloma annulare Facial Dermatoses Skin Diseases Collagen Diseases Facies Keloid Acne Keloid Granuloma Acne Vulgaris |
Lymphatic Diseases Exanthema Connective Tissue Diseases Lymphoproliferative Disorders Scleroderma, Localized Folliculitis Granuloma Annulare Cicatrix |
Hair Diseases Pathologic Processes Acneiform Eruptions Necrobiotic Disorders |