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Ultraviolet (UVA and UVB) Light Therapy in the Treatment of Inflammatory Skin Conditions
The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study
1 other identifier
interventional
28
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2000
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 9, 2005
CompletedFirst Posted
Study publicly available on registry
August 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMay 22, 2015
May 1, 2015
10.4 years
August 9, 2005
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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.
Photographs will also be taken.
Color photographs will be obtained at the end of the study.
Study Arms (2)
UVA1 Irradiation
EXPERIMENTALUVA 1 Irradiation (Sellemed UVA1 light source) up to 130 J/cm2
UVB Irridiation
EXPERIMENTALUVB Irradiation maximum dose of 4000 mJ/cm2
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Wang F, Garza LA, Cho S, Kafi R, Hammerberg C, Quan T, Hamilton T, Mayes M, Ratanatharathorn V, Voorhees JJ, Fisher GJ, Kang S. Effect of increased pigmentation on the antifibrotic response of human skin to UV-A1 phototherapy. Arch Dermatol. 2008 Jul;144(7):851-8. doi: 10.1001/archderm.144.7.851.
PMID: 18645136DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John J Voorhees, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Dermatology, Medical School
Study Record Dates
First Submitted
August 9, 2005
First Posted
August 11, 2005
Study Start
August 1, 2000
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
May 22, 2015
Record last verified: 2015-05