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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University of Michigan
ClinicalTrials.gov Identifier:
NCT00129415
First received: August 9, 2005
Last updated: October 3, 2011
Last verified: October 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study

Resource links provided by NLM:


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
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: UVA1 and UVB Irradiation
    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
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, see Learn About Clinical Studies.

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

Locations
United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Michigan
ClinicalTrials.gov Identifier: NCT00129415     History of Changes
Other Study ID Numbers: Derm 446
Study First Received: August 9, 2005
Last Updated: October 3, 2011
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

Additional relevant MeSH terms:
Alopecia
Dermatitis
Dermatitis, Atopic
Mycoses
Mycosis Fungoides
Psoriasis
Skin Diseases
Striae Distensae
Urticaria
Genetic Diseases, Inborn
Hair Diseases
Hypersensitivity
Hypersensitivity, Immediate
Hypotrichosis
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathological Conditions, Anatomical
Signs and Symptoms
Skin Diseases, Eczematous
Skin Diseases, Genetic
Skin Diseases, Papulosquamous
Skin Diseases, Vascular

ClinicalTrials.gov processed this record on October 20, 2014