UVA1 Light for Treatment of Scleroderma and Similar Conditions

Completed · Not applicable

Conditions studied: Scleroderma, Keloids, Other Fibrosing Conditions

In brief

The purpose of this investigation is to evaluate the effectiveness of an investigational device which is similar in appearance to a "tanning bed" but which emits ultraviolet irradiation of a specific wavelength known as UVA1. This device has not been approved by the FDA for general use in this country, as yet, but it has been used quite successfully in Europe for several years in treating such conditions as scleroderma, keloids, and other fibrosing conditions of the skin. Your participation in this study may yield important information regarding the safety and effectiveness of this form of light therapy for the treatment of these skin conditions which, at present, are difficult to treat.

Key facts

Study ID

NCT00476801

Run by

University of Michigan

People needed

27

Starts

2001-07-01

Expected to finish

2004-02-01

Last updated by the study team

2015-07-10

Who can join

Age: 10 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 10-80 years
• Clinical diagnosis of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare, and other related conditions associated with altered dermal matrix.
• At least two areas of comparable thickness/induration, one on each side, or one large sclerotic lesion that can be divided in half for UVA1 and sham UV therapy.
• No disease states or physical conditions which would impair evaluation of the test site.
• Willing and able to receive UVA1 as directed in the protocol, make evaluation visits, and follow protocol restrictions.
• Signed, written, witnessed, informed consent form.
• Must live within driving distance of Ann Arbor, Michigan.

You may not qualify if…

• History of photosensitivity.
• UVA1 irradiation hypersensitivity in a UVA1 photo-provocation test.
• Pregnant or nursing women.
• Involved in an investigational study within the previous 4 weeks.

Where it is running

• University of Michigan Department of Dermatology — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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