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

Primary Purpose

Atopic Dermatitis, Psoriasis, Alopecia

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
UVA1 Irradiation
UVB Irradiation
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring UVA1, UVB, atopic dermatitis, psoriasis, alopecia, mycosis fungoides (CTCL), urticaria, inflammatory dermatoses, stretch marks

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

UVA1 Irradiation

UVB Irridiation

Arm Description

UVA 1 Irradiation (Sellemed UVA1 light source) up to 130 J/cm2

UVB Irradiation maximum dose of 4000 mJ/cm2

Outcomes

Primary Outcome Measures

Clinical assessment to determine the effectiveness of light treatment for skin condition

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
Photographs will also be taken.

Full Information

First Posted
August 9, 2005
Last Updated
May 21, 2015
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00129415
Brief Title
Ultraviolet (UVA and UVB) Light Therapy in the Treatment of Inflammatory Skin Conditions
Official Title
The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
August 2000 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Psoriasis, Alopecia, Mycosis Fungoides, Urticaria, Dermatoses, Stretch Marks
Keywords
UVA1, UVB, atopic dermatitis, psoriasis, alopecia, mycosis fungoides (CTCL), urticaria, inflammatory dermatoses, stretch marks

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UVA1 Irradiation
Arm Type
Experimental
Arm Description
UVA 1 Irradiation (Sellemed UVA1 light source) up to 130 J/cm2
Arm Title
UVB Irridiation
Arm Type
Experimental
Arm Description
UVB Irradiation maximum dose of 4000 mJ/cm2
Intervention Type
Procedure
Intervention Name(s)
UVA1 Irradiation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
UVB Irradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
Photographs will also be taken.
Time Frame
Color photographs will be obtained at the end of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Voorhees, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Department of Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18645136
Citation
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.
Results Reference
derived

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

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