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Ultraviolet (UVA and UVB) Light Therapy in the Treatment of Inflammatory Skin Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129415
Recruitment Status : Terminated (Slow enrollment)
First Posted : August 11, 2005
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Yolanda Rosi Helfrich, University of Michigan

Study Description
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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.


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

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : August 2000
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. Photographs will also be taken. [ Time Frame: Color photographs will be obtained at the end of the study. ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

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
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Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Study Chair: John J Voorhees, MD University of Michigan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yolanda Rosi Helfrich, Assistant Professor of Dermatology, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT00129415    
Other Study ID Numbers: Derm 446
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Yolanda Rosi Helfrich, University of Michigan:
UVA1
UVB
atopic dermatitis
psoriasis
alopecia
 mycosis fungoides (CTCL)
urticaria
inflammatory dermatoses
stretch marks
Additional relevant MeSH terms:
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Mycoses
Mycosis Fungoides
Dermatitis, Atopic
Psoriasis
Dermatitis
Eczema
Alopecia
Urticaria
Skin Diseases
Striae Distensae
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical
Bacterial Infections and Mycoses
Infections
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases