An interventional study of German manufactured UVA1 light emitting device in Scleroderma, Keloids and Other Fibrosing Conditions, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-10.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 27 is below the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
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Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Exclusion Criteria:
The dose and scheduling will be similar to those being successfully used in Germany: up to 130J/cm2 from a UVA1 Sellamed irradiation device (German manufactured UVA1 light emitting device) with irradiations up to 5 times per week for up to 14 weeks on one side of the face. Then a cross-over treatment an equal length of time.
Device: German manufactured UVA1 light emitting device
No treatment on the opposite side of the face as the UVA1 treatment for up to 14 weeks. Then a cross-over treatment an equal length of time.
The UVA1 dose will be up to 130 J/cm2.
Plaque thickness, plaque hardness, patient mobility
Time frame: 28 weeks
Levels of collagen and mmp induction
Time frame: 28 weeks
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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