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| Sponsored by: |
University of Michigan |
|---|---|
| Information provided by: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00476697 |
Purpose
The purpose of this investigation is to evaluate the effectiveness of high-dose UVA1 irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar from growth of fibrous tissue), scleroderma (deposits of fibrous tissue in the skin) and acne keloidalis nuchae (keloids on the back of the neck or hairline) old burn scars, granuloma annulare or other similar skin conditions. This UVA1 dosing schedule has been used successfully in Germany for various skin diseases, such as the above mentioned scleroderma.
| Condition | Intervention |
|---|---|
|
Keloid Scleroderma Scars Granuloma Annulare Acne Keloidalis Nuchae |
Device: German manufactured UVA1 emitting light system |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | The Effectiveness of UVA1 Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study |
| Estimated Enrollment: | 50 |
| Study Start Date: | January 1997 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ultraviolet rays from the sun that reach the earth surface are divided into shorter wavelength, hence high energy, UVB (290-320nm) and longer wavelength, hence low energy UVA (320-400nm). The wavelengths of light that cause sunburn and are associated with skin cancer causation is the high energy UVB. UVA wavelengths can be further divided into relatively shorter wavelength, hence higher energy UVA2 (320-340nm) and longer wavelength, lower energy UVA1 (340-400nm). Phototherapy light boxes used in our clinic for the treatment of psoriasis, atopic dermatitis, and pruritus, as well as those used in tanning salons emit both UVB and UVA wavelengths of light. The advantages of using UVA1 light source in the treatment of skin conditions are 1) lack of skin cancer and sunburn causing rays (UVB) and 2) as a consequence, the ability to treat patients more safely and longer.
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 (1-3). The mode of action of UVA1 treatment is not completely understood, however, local immuno-modulation appears to be important (4). UVA1 has also been shown to stimulate collagenase activity in a dose dependent manner in the dermis (5,6). We postulate, therefore, that UVA1 in appropriate doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen. Based on the result of this pilot study, a formal controlled clinical investigation is planned.
Eligibility| Ages Eligible for Study: | 10 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Michigan | |
| University of Michigan Department of Dermatology | |
| Ann Arbor, Michigan, United States, 48109-0314 | |
| Principal Investigator: | Sewon Kang, MD | University of Michigan hospital |
More Information
| Responsible Party: | University of Michigan Department of Dermatology ( Sewon Kang, MD, Professor and Director of Clinical Pharmacology ) |
| Study ID Numbers: | Derm 364 |
| Study First Received: | May 18, 2007 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00476697 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
UVA1 scleroderma keloids morphea light therapy |
|
Facial Dermatoses Skin Diseases Collagen Diseases Facies Keloid Acne Keloid Granuloma Acne Vulgaris |
Lymphatic Diseases Exanthema Connective Tissue Diseases Scleroderma Lymphoproliferative Disorders Granuloma Annulare Folliculitis Cicatrix |
|
Hair Diseases Facial Dermatoses Collagen Diseases Skin Diseases Keloid Acne Keloid Granuloma Lymphatic Diseases |
Pathologic Processes Acneiform Eruptions Necrobiotic Disorders Connective Tissue Diseases Lymphoproliferative Disorders Granuloma Annulare Folliculitis Cicatrix |