Psoriasis Clinical Trial
Official title:
The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study
Verified date | May 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this investigation is to study the effectiveness of longer wavelength UVA1
(340-400nm) or shorter wavelength ultraviolet B [UVB] (290-320nm) irradiation in the
treatment of inflammatory skin conditions (such as: atopic dermatitis, psoriasis, mycosis
fungoides, alopecia areata, stretch marks and urticaria).
This research study aims 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 Food and Drug
Administration (FDA) for general use in this country, as of yet, but it has been used quite
successfully in Europe for several years in treating such conditions as scleroderma, atopic
dermatitis, urticaria pigmentosa and other skin conditions.
Instead of UVA1 therapy, patients may receive ultraviolet radiation of a specific wavelength
known as UVB. UVA1 light is a longer wavelength and therefore a lower energy wavelength than
UVB. UVB light is often the light associated with getting a sunburn since it has a higher
level of energy. UVB light has been used successfully in the treatment of many skin
conditions.
Status | Terminated |
Enrollment | 28 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Ages: 10-80 years - Clinical diagnosis of inflammatory dermatoses such as atopic dermatitis, psoriasis, mycosis fungoides, alopecia areata, and urticaria. - No disease states or physical conditions that would impair evaluation of the test site. - Willing and able to receive UVA1 or UVB, as directed in the protocol; make evaluation visits; and follow protocol restrictions. - Signed, written, witnessed, informed consent form. - Must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study. Exclusion Criteria: - History of photosensitivity (development of hives or bumps with exposure to light). - UVA1 or UVB irradiation hypersensitivity in a UVA1/UVB photo-provocation test. - Pregnant or nursing women. - Involved in an investigational study within the previous 4 weeks. - Presence of bacterial superinfection. - Taken oral therapy for skin condition within the last 4 weeks - Topical steroid therapy within the last 2 weeks - History of excessive scar formation or keloids |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Department of Dermatology | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical assessment to determine the effectiveness of light treatment for skin condition | Subjects will be evaluated at weeks 1, 2, and 4, then every month until the end of the study | No | |
Secondary | 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 | At completion of the study. | No | |
Secondary | Photographs will also be taken. | Color photographs will be obtained at the end of the study. | No |
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