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

May 18, 2007
October 3, 2011
January 1997
May 2011   (final data collection date for primary outcome measure)
Measurement of plaque thickness, increase in mobility, plaque hardness [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Measurement of plaque thickness, increase in mobility, plaque hardness [ Time Frame: 16 weeks ]
Complete list of historical versions of study NCT00476697 on ClinicalTrials.gov Archive Site
Analysis of collagen levels, mmp induction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Analysis of collagen levels, mmp induction [ Time Frame: 16 weeks ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Keloid
  • Scleroderma
  • Scars
  • Granuloma Annulare
  • Acne Keloidalis Nuchae
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
10 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00476697
Derm 364
No
University of Michigan
University of Michigan
Not Provided
Principal Investigator: Sewon Kang, MD University of Michigan hospital
University of Michigan
October 2011

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