Ultraviolet (UVA and UVB) Light Therapy in the Treatment of Inflammatory Skin Conditions - Full Text View

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00129415

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Hair Diseases and Hair Loss Hives Psoriasis Radiation Therapy Skin Conditions

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

The affected areas on the body will be treated with UVA1 (Sellemed UVA1 light source)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.

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.

Eligibility

Ages Eligible for Study:	10 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129415

Locations

United States, Michigan
University of Michigan Department of Dermatology	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kathy Keeley, BS ktkeeley@umich.edu
Principal Investigator: Sewon Kang, MD

Sponsors and Collaborators

University of Michigan

Investigators

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 National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	University of Michigan Department of Dermatology ( Sewon Kang, MD, Professor and Director of Clinical Pharmacology )
Study ID Numbers:	Derm 446
Study First Received:	August 9, 2005
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00129415 History of Changes
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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypotrichosis
Dermatitis, Atopic
Sezary Syndrome
Mycosis Fungoides
Mycoses
Hypersensitivity
Psoriasis
Cutaneous T-cell Lymphoma
Alopecia
Lymphoma, T-Cell
Skin Diseases, Eczematous
Skin Diseases, Genetic

Lymphoma
Dermatitis
Immunoproliferative Disorders
Skin Diseases
Urticaria
Lymphatic Diseases
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Skin Diseases, Papulosquamous
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hypotrichosis
Dermatitis, Atopic
Sezary Syndrome
Mycosis Fungoides
Mycoses
Hypersensitivity
Psoriasis
Alopecia
Lymphoma, T-Cell
Skin Diseases, Eczematous
Skin Diseases, Genetic
Lymphoma
Dermatitis
Hair Diseases

Skin Diseases, Vascular
Immunoproliferative Disorders
Neoplasms by Histologic Type
Skin Diseases
Immune System Diseases
Urticaria
Lymphatic Diseases
Neoplasms
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Skin Diseases, Papulosquamous
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on July 02, 2009