Study Stopped
inactivity
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
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 1997
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 22, 2007
CompletedJuly 27, 2015
July 1, 2015
6.5 years
May 18, 2007
July 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of plaque thickness, increase in mobility, plaque hardness
16 weeks
Secondary Outcomes (1)
Analysis of collagen levels, mmp induction
16 weeks
Study Arms (1)
UVA1 Irradiation
EXPERIMENTALUVA1 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109-0314, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yolanda Helfrich, MD
University of Michigan hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Program for Clinical Research In Dermatology
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 22, 2007
Study Start
January 1, 1997
Primary Completion
July 1, 2003
Study Completion
July 1, 2003
Last Updated
July 27, 2015
Record last verified: 2015-07