Ultraviolet (UVA and UVB) Light Therapy in the Treatment of Inflammatory Skin Conditions
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis Psoriasis Alopecia Mycosis Fungoides Urticaria Dermatoses Stretch Marks |
Procedure: UVA1 and UVB Irradiation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study |
- Clinical assessment to determine the effectiveness of light treatment for skin condition [ Time Frame: Subjects will be evaluated at weeks 1, 2, and 4, then every month until the end of the study ] [ Designated as safety issue: No ]
- 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 [ Time Frame: At completion of the study. ] [ Designated as safety issue: No ]
- Photographs will also be taken. [ Time Frame: Color photographs will be obtained at the end of the study. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2000 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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Procedure: UVA1 and UVB Irradiation
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. 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.
Eligibility| Ages Eligible for Study: | 10 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| University of Michigan Department of Dermatology | |
| Ann Arbor, Michigan, United States, 48109 | |
| Study Chair: | John J Voorhees, MD | University of Michigan |
More Information
No publications provided by University of Michigan
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00129415 History of Changes |
| Other Study ID Numbers: | Derm 446 |
| Study First Received: | August 9, 2005 |
| Last Updated: | October 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
UVA1 UVB atopic dermatitis psoriasis alopecia |
mycosis fungoides (CTCL) urticaria inflammatory dermatoses stretch marks |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Dermatitis Dermatitis, Atopic Mycoses Mycosis Fungoides Psoriasis Skin Diseases Urticaria Striae Distensae Hypotrichosis Hair Diseases Pathological Conditions, Anatomical Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Skin Diseases, Papulosquamous Skin Diseases, Vascular |
ClinicalTrials.gov processed this record on May 16, 2013