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UVA1 Light for Scleroderma and Similar Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00476697
Recruitment Status : Terminated (inactivity)
First Posted : May 22, 2007
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):
Yolanda Rosi Helfrich, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Keloid Scleroderma Scars Granuloma Annulare Acne Keloidalis Nuchae Device: German manufactured UVA1 emitting light system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 1997
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

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.
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.

Primary Outcome Measures :
  1. Measurement of plaque thickness, increase in mobility, plaque hardness [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Analysis of collagen levels, mmp induction [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00476697

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United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109-0314
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Yolanda Helfrich, MD University of Michigan hospital
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Responsible Party: Yolanda Rosi Helfrich, Director Program for Clinical Research In Dermatology, University of Michigan Identifier: NCT00476697    
Other Study ID Numbers: Derm 364
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Keywords provided by Yolanda Rosi Helfrich, University of Michigan:
light therapy
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Granuloma Annulare
Acne Keloid
Connective Tissue Diseases
Skin Diseases
Collagen Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Necrobiotic Disorders
Acneiform Eruptions
Hair Diseases