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UVA1 Light for Scleroderma and Similar Conditions

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ClinicalTrials.gov Identifier: NCT00476697
Recruitment Status : Terminated (inactivity)
First Posted : May 22, 2007
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Yolanda Rosi Helfrich, University of Michigan

Tracking Information
First Submitted Date  ICMJE May 18, 2007
First Posted Date  ICMJE May 22, 2007
Last Update Posted Date July 27, 2015
Study Start Date  ICMJE January 1997
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2007)		 Measurement of plaque thickness, increase in mobility, plaque hardness [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2007)		 Analysis of collagen levels, mmp induction [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UVA1 Light for Scleroderma and Similar Conditions
Official Title  ICMJE The Effectiveness of UVA1 Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Keloid
  • Scleroderma
  • Scars
  • Granuloma Annulare
  • Acne Keloidalis Nuchae
Intervention  ICMJE Device: German manufactured UVA1 emitting light system
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.
Study Arms  ICMJE 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.
Intervention: Device: German manufactured UVA1 emitting light system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 10, 2015)		 23
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2007)		 50
Actual Study Completion Date  ICMJE July 2003
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00476697
Other Study ID Numbers  ICMJE Derm 364
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yolanda Rosi Helfrich, University of Michigan
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Michigan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yolanda Helfrich, MD University of Michigan hospital
PRS Account University of Michigan
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP