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Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix

Primary Purpose

Keloid, Scleroderma, Localized, Acne Keloidalis

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

About this trial

This is an interventional prevention trial for Keloid focused on measuring UVB, keloid, scleroderma, acne keloidalis nuchae, scars, granuloma annulare

Eligibility Criteria

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

Inclusion Criteria: In good general health and between 10-80 years of age. Willing and able to receive UVB, as directed in the protocol; make evaluation visits; follow protocol restrictions; and sign a written, witnessed, informed consent form. Have a clinical diagnosis of keloid, scleroderma, old burn scars, granuloma annulare, or acne keloidalis nuchae. No disease states or physical conditions that would impair evaluation of the test site 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: Have a history of photosensitivity (development of hives or bumps with exposure to light) or experience hypersensitivity in a UVB photo-provocation test. Have participated in another investigational study in the past 4 weeks, taken oral therapy for skin condition, or on photosensitizing medications. Pregnant, nursing, or planning to become pregnant during the study.

Sites / Locations

  • University of Michigan Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UVB Irradiation

Arm Description

A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.

Outcomes

Primary Outcome Measures

Improvement in appearance of keloids (hypertrophic scars), scleroderma, acne keloidalis nuchae,old burn scars, granuloma annulare, and related conditions with altered dermal matrix

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
April 30, 2015
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00129428
Brief Title
Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix
Official Title
The Effectiveness of UVB Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (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
This research study will evaluate the effectiveness of high dose UVB light therapy in the treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare or related conditions.
Detailed Description
Keloid, scleroderma, acne keloidalis nuchae, and burn scars are all characterized by collagenous thickening of the skin resulting in superficial and deep cutaneous sclerosis. Treatments for these disabling conditions are inadequate at present. Recently, in non-controlled studies, UVA1 was shown to induce improvement in patients with scleroderma, granuloma annulare and urticaria pigmentosa. However, UVA1 is unable to penetrate pigmented skin at an effective level to activate matrix metalloproteinases (MMPs). The investigators' preliminary data show that high dose UVB (160 mJ/cm2) will penetrate pigmented skin and activate the cellular pathways necessary to stimulate MMPs. They postulate, therefore, that in pigmented skin, higher than usual UVB doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen via activation of MMP pathways. The purpose of this research project is to study the effectiveness of high dose UVB (290-320nm at up to 320mJ/cm2) irradiation for the treatment of skin conditions with altered dermal matrix in patients with increased skin pigmentation. These disorders include but are not limited to keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, and granuloma annulare. Up to fifty patients with one of these diagnoses or related conditions will receive UVB irradiation up to 5 times per week, for 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid, Scleroderma, Localized, Acne Keloidalis, Scars, Granuloma Annulare
Keywords
UVB, keloid, scleroderma, acne keloidalis nuchae, scars, granuloma annulare

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UVB Irradiation
Arm Type
Experimental
Arm Description
A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.
Intervention Type
Procedure
Intervention Name(s)
UVB Irradiation
Intervention Description
A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.
Primary Outcome Measure Information:
Title
Improvement in appearance of keloids (hypertrophic scars), scleroderma, acne keloidalis nuchae,old burn scars, granuloma annulare, and related conditions with altered dermal matrix
Time Frame
Subjects will be evaluated at weeks 1, 2, 4, and then at monthly intervals 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
Assays will be performed after specimen collection
Title
Photographs will also be taken.
Time Frame
At baseline and at 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: In good general health and between 10-80 years of age. Willing and able to receive UVB, as directed in the protocol; make evaluation visits; follow protocol restrictions; and sign a written, witnessed, informed consent form. Have a clinical diagnosis of keloid, scleroderma, old burn scars, granuloma annulare, or acne keloidalis nuchae. No disease states or physical conditions that would impair evaluation of the test site 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: Have a history of photosensitivity (development of hives or bumps with exposure to light) or experience hypersensitivity in a UVB photo-provocation test. Have participated in another investigational study in the past 4 weeks, taken oral therapy for skin condition, or on photosensitizing medications. Pregnant, nursing, or planning to become pregnant during the study.
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

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Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix

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