UVA1 Light for Scleroderma and Similar Conditions
Primary Purpose
Keloid, Scleroderma, Scars
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
German manufactured UVA1 emitting light system
Sponsored by
About this trial
This is an interventional treatment trial for Keloid focused on measuring UVA1, scleroderma, keloids, morphea, light therapy
Eligibility Criteria
Inclusion Criteria:
- Age: 10-80 years
- Clinical diagnosis of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare, and other related conditions associated with altered dermal matrix.
- No disease states or physical conditions which would impair evaluation of the test site.
- Willing and able to receive UVA1 as directed in the protocol, make evaluation visits, and follow protocol restrictions.
- Signed, written, witnessed, informed consent form.
- Must live within driving distance of Ann Arbor, Michigan.
Exclusion Criteria:
- History of photosensitivity.
- Pregnant or nursing women.
- Systemic therapy for the fibrosing skin condition within 30 days prior to study enrollment.
- Involved in an investigational study within the previous 4 weeks.
Sites / Locations
- University of Michigan Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UVA1 Irradiation
Arm Description
UVA1 irradiaton up to 5 times per week, for up to 16 weeks using German manufactured UVA1 emitting light system. UVA1 dose will be applied with up to 130 J/cm2.
Outcomes
Primary Outcome Measures
Measurement of plaque thickness, increase in mobility, plaque hardness
Secondary Outcome Measures
Analysis of collagen levels, mmp induction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00476697
Brief Title
UVA1 Light for Scleroderma and Similar Conditions
Official Title
The Effectiveness of UVA1 Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
inactivity
Study Start Date
January 1997 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (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 evaluate the effectiveness of high-dose UVA1 irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar from growth of fibrous tissue), scleroderma (deposits of fibrous tissue in the skin) and acne keloidalis nuchae (keloids on the back of the neck or hairline) old burn scars, granuloma annulare or other similar skin conditions. This UVA1 dosing schedule has been used successfully in Germany for various skin diseases, such as the above mentioned scleroderma.
Detailed Description
Ultraviolet rays from the sun that reach the earth surface are divided into shorter wavelength, hence high energy, UVB (290-320nm) and longer wavelength, hence low energy UVA (320-400nm). The wavelengths of light that cause sunburn and are associated with skin cancer causation is the high energy UVB. UVA wavelengths can be further divided into relatively shorter wavelength, hence higher energy UVA2 (320-340nm) and longer wavelength, lower energy UVA1 (340-400nm). Phototherapy light boxes used in our clinic for the treatment of psoriasis, atopic dermatitis, and pruritus, as well as those used in tanning salons emit both UVB and UVA wavelengths of light. The advantages of using UVA1 light source in the treatment of skin conditions are 1) lack of skin cancer and sunburn causing rays (UVB) and 2) as a consequence, the ability to treat patients more safely and longer.
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 (1-3). The mode of action of UVA1 treatment is not completely understood, however, local immuno-modulation appears to be important (4). UVA1 has also been shown to stimulate collagenase activity in a dose dependent manner in the dermis (5,6). We postulate, therefore, that UVA1 in appropriate doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen.
Based on the result of this pilot study, a formal controlled clinical investigation is planned.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid, Scleroderma, Scars, Granuloma Annulare, Acne Keloidalis Nuchae
Keywords
UVA1, scleroderma, keloids, morphea, light therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UVA1 Irradiation
Arm Type
Experimental
Arm Description
UVA1 irradiaton up to 5 times per week, for up to 16 weeks using German manufactured UVA1 emitting light system. UVA1 dose will be applied with up to 130 J/cm2.
Intervention Type
Device
Intervention Name(s)
German manufactured UVA1 emitting light system
Intervention Description
The dose and scheduling of irradiation is as follows: Up to 130J/cm2 from a UVA1 Sellamed irradiation device with irradiations up to 5 times per week.
Primary Outcome Measure Information:
Title
Measurement of plaque thickness, increase in mobility, plaque hardness
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Analysis of collagen levels, mmp induction
Time Frame
16 weeks
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:
Age: 10-80 years
Clinical diagnosis of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare, and other related conditions associated with altered dermal matrix.
No disease states or physical conditions which would impair evaluation of the test site.
Willing and able to receive UVA1 as directed in the protocol, make evaluation visits, and follow protocol restrictions.
Signed, written, witnessed, informed consent form.
Must live within driving distance of Ann Arbor, Michigan.
Exclusion Criteria:
History of photosensitivity.
Pregnant or nursing women.
Systemic therapy for the fibrosing skin condition within 30 days prior to study enrollment.
Involved in an investigational study within the previous 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yolanda Helfrich, MD
Organizational Affiliation
University of Michigan hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Department of Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0314
Country
United States
12. IPD Sharing Statement
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UVA1 Light for Scleroderma and Similar Conditions
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