The purpose of this investigation is to study the effectiveness of longer wavelength UVA1 (340-400nm) or shorter wavelength UVB (290-320nm) irradiation in the treatment of inflammatory skin conditions (such as: atopic dermatitis, psoriasis, mycosis fungoides, alopecia areata, 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 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, atopic dermatitis, urticaria pigmentosa and other skin conditions.

Instead of UVA1 therapy, you 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.

Condition	Intervention	Phase
Atopic Dermatitis Psoriasis Alopecia mycosis fungoides (CTCL) Urticaria Inflammatory Dermatoses	Procedure: UVA1 and UVB Irradiation	Phase II Phase III

Further Study Details: 

Primary Outcomes: Clinical assessment to determine effectiveness of light treatment for skin condition.
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

The purpose of this investigation is to study the effectiveness of longer wavelength UVA1 (340-400nm) or shorter wavelength UVB (290-320nm) irradiation in the treatment of inflammatory skin conditions. Inflammatory dermatoses refer to conditions like atopic dermatitis (eczema) and psoriasis in which circulating leukocytes (T cells, neutrophils, and monocytes) infiltrate the skin. The infiltrating cells may be of malignant phenotype as in mycosis fungoides (cutaneous T cell lymphoma-CTCL). Up to 50 patients with one of these diagnoses or related conditions will participate in this study. The affected areas on the body will be treated with UVA1 or UVB for up to 5 times per week for 16 weeks. The UVA1 dose will be up to 130 J/cm2. The maximum UVB dose will be 4000 mJ/cm2 9. This UVA1 dosing schedule has been safely used in Germany for treating patients with atopic dermatitis, mycosis fungoides, granuloma annulare, scleroderma, and urticaria pigmentosa. Subjects will be evaluated clinically at baseline, weeks 1, 2, 4, and then at monthly intervals. More frequent evaluation may be required depending on the condition being studied. Paired skin biopsies may be taken from involved and uninvolved (or treated and untreated) areas before and during UV therapy.

Ages Eligible for Study:  10 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Age: 10-80 years
2. Clinical diagnosis of inflammatory dermatoses such as atopic dermatitis, psoriasis, mycosis fungoides, alopecia areata, and urticaria.
3. No disease states or physical conditions that would impair evaluation of the test site.
4. Willing and able to receive UVA1 or UVB as directed in the protocol, make evaluation visits, and follow protocol restrictions.
5. Signed, written, witnessed, informed consent form.

Exclusion Criteria:

1. History of photosensitivity (development of hives or bumps with exposure to light).
2. UVA1 or UVB irradiation hypersensitivity in a UVA1/UVB photo-provocation test.
3. Pregnant or nursing women.
4. Involved in an investigational study within the previous 4 weeks.
5. Presence of bacterial superinfection.
6. Taken oral therapy for your skin condition within the last 4 weeks
7. Topical steroid therapy within the last 2 weeks
8. History of excessive scar formation or keloids

Please refer to this study by ClinicalTrials.gov identifier  NCT00129415

Michigan
      University of Michigan Department of Dermatology, Ann Arbor,  Michigan,  48109,  United States; Recruiting

Study chairs or principal investigators

John J Voorhees, MD,  Study Chair,  University of Michigan   

Study ID Numbers:  Derm 446
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129415
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23