The Effectiveness of UVB Light Therapy in the Treatment of Skin Conditions with Altered Dermal Matrix - Article Pimples; Zits
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
Acne Keloidalis Nuchae
| Procedure: UVB Irradiation ||Phase II |
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
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.
•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.
•No disease states or physical conditions that would impair evaluation of the test site
•Have a history of photosensitivity (development of hives or bumps with exposure to light) or experience hypersensitivity in an UVB photo-provocation test.
•Participate if you are pregnant, or nursing, or planning to become pregnant during the study.
Location and Contact Information
University of Michigan Department of Dermatology, Ann Arbor, Michigan, 48109, United States; Recruiting
Sewon Kang, MD 734-936-4192 firstname.lastname@example.org
Sewon Kang, MD, Principal Investigator
John J Voorhees, MD, Study Chair, University of Michigan
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