Ultraviolet (UVA and UVB) Light Therapy in the Treatment of Inflammatory Skin Conditions
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.
|Atopic Dermatitis Psoriasis Alopecia Mycosis Fungoides Urticaria Dermatoses Stretch Marks||Procedure: UVA1 Irradiation Procedure: UVB Irradiation||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
- 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. ]
- Photographs will also be taken. [ Time Frame: Color photographs will be obtained at the end of the study. ]
|Study Start Date:||August 2000|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: UVA1 Irradiation
UVA 1 Irradiation (Sellemed UVA1 light source) up to 130 J/cm2
Procedure: UVA1 Irradiation
The affected areas on the body will be treated with UVA1 (Sellemed UVA1 light source) for up to 5 times per week for 16 weeks. The UVA1 dose will be up to 130 J/cm2.
Experimental: UVB Irridiation
UVB Irradiation maximum dose of 4000 mJ/cm2
Procedure: UVB Irradiation
The affected areas on the body will be treated with UVB light for up to 5 times per week for 16 weeks. The maximum UVB dose will be 4000 mJ/cm2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129415
|United States, Michigan|
|University of Michigan Department of Dermatology|
|Ann Arbor, Michigan, United States, 48109|
|Study Chair:||John J Voorhees, MD||University of Michigan|