UVA1 Light for Treatment of Scleroderma and Similar Conditions
Primary Purpose
Scleroderma, Keloids, Other Fibrosing Conditions
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
German manufactured UVA1 light emitting device
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma focused on measuring UVA1, scleroderma, keloids, light therapy, morphea
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.
- At least two areas of comparable thickness/induration, one on each side, or one large sclerotic lesion that can be divided in half for UVA1 and sham UV therapy.
- 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.
- UVA1 irradiation hypersensitivity in a UVA1 photo-provocation test.
- Pregnant or nursing women.
- 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 2
Arm Type
Experimental
No Intervention
Arm Label
UVA1 irradiation
Control
Arm Description
The dose and scheduling will be similar to those being successfully used in Germany: up to 130J/cm2 from a UVA1 Sellamed irradiation device (German manufactured UVA1 light emitting device) with irradiations up to 5 times per week for up to 14 weeks on one side of the face. Then a cross-over treatment an equal length of time.
No treatment on the opposite side of the face as the UVA1 treatment for up to 14 weeks. Then a cross-over treatment an equal length of time.
Outcomes
Primary Outcome Measures
Plaque thickness, plaque hardness, patient mobility
Secondary Outcome Measures
Levels of collagen and mmp induction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00476801
Brief Title
UVA1 Light for Treatment of Scleroderma and Similar Conditions
Official Title
The Effectiveness Of UVA1 Irradiation In The Treatment Of Skin Conditions With Altered Dermal Matrix: A Controlled, Cross-Over Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
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 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 FDA for general use in this country, as yet, but it has been used quite successfully in Europe for several years in treating such conditions as scleroderma, keloids, and other fibrosing conditions of the skin. Your participation in this study may yield important information regarding the safety and effectiveness of this form of light therapy for the treatment of these skin conditions which, at present, are difficult to treat.
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/UVA2) and 2) as a consequence, the ability to treat patients more safely.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Keloids, Other Fibrosing Conditions
Keywords
UVA1, scleroderma, keloids, light therapy, morphea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UVA1 irradiation
Arm Type
Experimental
Arm Description
The dose and scheduling will be similar to those being successfully used in Germany: up to 130J/cm2 from a UVA1 Sellamed irradiation device (German manufactured UVA1 light emitting device) with irradiations up to 5 times per week for up to 14 weeks on one side of the face. Then a cross-over treatment an equal length of time.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment on the opposite side of the face as the UVA1 treatment for up to 14 weeks. Then a cross-over treatment an equal length of time.
Intervention Type
Device
Intervention Name(s)
German manufactured UVA1 light emitting device
Intervention Description
The UVA1 dose will be up to 130 J/cm2.
Primary Outcome Measure Information:
Title
Plaque thickness, plaque hardness, patient mobility
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Levels of collagen and mmp induction
Time Frame
28 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.
At least two areas of comparable thickness/induration, one on each side, or one large sclerotic lesion that can be divided in half for UVA1 and sham UV therapy.
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.
UVA1 irradiation hypersensitivity in a UVA1 photo-provocation test.
Pregnant or nursing women.
Involved in an investigational study within the previous 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sewon Kang, 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 Treatment of Scleroderma and Similar Conditions
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