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
|Condition or disease||Intervention/treatment||Phase|
|Keloid Scleroderma Scars Granuloma Annulare Acne Keloidalis Nuchae||Device: German manufactured UVA1 emitting light system||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Measurement of plaque thickness, increase in mobility, plaque hardness [ Time Frame: 16 weeks ]
- Analysis of collagen levels, mmp induction [ Time Frame: 16 weeks ]
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 ClinicalTrials.gov identifier (NCT number): NCT00476697
|United States, Michigan|
|University of Michigan Department of Dermatology|
|Ann Arbor, Michigan, United States, 48109-0314|
|Principal Investigator:||Yolanda Helfrich, MD||University of Michigan hospital|