UVA1 Light for Treatment of Scleroderma and Similar Conditions

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00476801
First received: May 18, 2007
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Scleroderma
Keloids
Other Fibrosing Conditions
Device: German manufactured UVA1 light emitting device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness Of UVA1 Irradiation In The Treatment Of Skin Conditions With Altered Dermal Matrix: A Controlled, Cross-Over Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Plaque thickness, plaque hardness, patient mobility [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Levels of collagen and mmp induction [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: July 2001
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: German manufactured UVA1 light emitting device
The UVA1 dose will be up to 130 J/cm2.
Experimental: 2 Device: German manufactured UVA1 light emitting device
The UVA1 dose will be up to 130 J/cm2.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476801

Locations
United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109-0314
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Sewon Kang, MD University of Michigan hospital
  More Information

No publications provided

Responsible Party: Sewon Kang, MD, Professor and Director Clinical Pharmacology, University of Michigan Department of Dermatology
ClinicalTrials.gov Identifier: NCT00476801     History of Changes
Other Study ID Numbers: Derm 438
Study First Received: May 18, 2007
Last Updated: June 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
UVA1
scleroderma
keloids
light therapy
morphea

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Keloid
Connective Tissue Diseases
Skin Diseases
Collagen Diseases
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014