Ultraviolet (UVA and UVB) Light Therapy in the Treatment of Inflammatory Skin Conditions
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|ClinicalTrials.gov Identifier: NCT00129415|
Recruitment Status : Terminated (Slow enrollment)
First Posted : August 11, 2005
Last Update Posted : May 22, 2015
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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 or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Psoriasis Alopecia Mycosis Fungoides Urticaria Dermatoses Stretch Marks||Procedure: UVA1 Irradiation Procedure: UVB Irradiation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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.
- 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. ]
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|Ages Eligible for Study:||10 Years to 80 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Responsible Party:||Yolanda Rosi Helfrich, Assistant Professor of Dermatology, Medical School, University of Michigan|
|Other Study ID Numbers:||
|First Posted:||August 11, 2005 Key Record Dates|
|Last Update Posted:||May 22, 2015|
|Last Verified:||May 2015|
mycosis fungoides (CTCL)
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases
Bacterial Infections and Mycoses
Pathological Conditions, Anatomical
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type