- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476697
UVA1 Light for Scleroderma and Similar Conditions
The Effectiveness of UVA1 Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109-0314
- University of Michigan Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: UVA1 Irradiation
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of plaque thickness, increase in mobility, plaque hardness
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of collagen levels, mmp induction
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yolanda Helfrich, MD, University of Michigan Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Connective Tissue Diseases
- Fibrosis
- Acneiform Eruptions
- Cicatrix
- Hair Diseases
- Collagen Diseases
- Necrobiotic Disorders
- Folliculitis
- Scleroderma, Systemic
- Scleroderma, Diffuse
- Granuloma
- Keloid
- Granuloma Annulare
- Acne Keloid
Other Study ID Numbers
- Derm 364
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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