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UVA1 Light for Scleroderma and Similar Conditions

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University of Michigan
ClinicalTrials.gov Identifier:
NCT00476697
First received: May 18, 2007
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Keloid
Scleroderma
Scars
Granuloma Annulare
Acne Keloidalis Nuchae
Device: German manufactured UVA1 emitting light system

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of UVA1 Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Measurement of plaque thickness, increase in mobility, plaque hardness [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of collagen levels, mmp induction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 1997
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  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.
  • 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.
  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: NCT00476697

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: University of Michigan
ClinicalTrials.gov Identifier: NCT00476697     History of Changes
Other Study ID Numbers: Derm 364
Study First Received: May 18, 2007
Last Updated: October 3, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acne Keloid
Granuloma Annulare
Scleroderma, Diffuse
Scleroderma, Systemic
Acneiform Eruptions
Collagen Diseases
Connective Tissue Diseases
Facial Dermatoses
Folliculitis
Granuloma
Hair Diseases
Keloid
Necrobiotic Disorders
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014