UVA1 Light for Treatment of Scleroderma and Similar Conditions
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|ClinicalTrials.gov Identifier: NCT00476801|
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : July 10, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Scleroderma Keloids Other Fibrosing Conditions||Device: German manufactured UVA1 light emitting device||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/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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effectiveness Of UVA1 Irradiation In The Treatment Of Skin Conditions With Altered Dermal Matrix: A Controlled, Cross-Over Study|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||February 2004|
Experimental: UVA1 irradiation
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
The UVA1 dose will be up to 130 J/cm2.
No Intervention: Control
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.
- Plaque thickness, plaque hardness, patient mobility [ Time Frame: 28 weeks ]
- Levels of collagen and mmp induction [ Time Frame: 28 weeks ]
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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|
- 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.
- At least two areas of comparable thickness/induration, one on each side, or one large sclerotic lesion that can be divided in half for UVA1 and sham UV therapy.
- 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.
- History of photosensitivity.
- UVA1 irradiation hypersensitivity in a UVA1 photo-provocation test.
- Pregnant or nursing women.
- Involved in an investigational study within the previous 4 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): NCT00476801
|United States, Michigan|
|University of Michigan Department of Dermatology|
|Ann Arbor, Michigan, United States, 48109-0314|
|Principal Investigator:||Sewon Kang, MD||University of Michigan hospital|
|Responsible Party:||Sewon Kang, MD, Professor and Director Clinical Pharmacology, University of Michigan Department of Dermatology|
|Other Study ID Numbers:||
|First Posted:||May 22, 2007 Key Record Dates|
|Last Update Posted:||July 10, 2015|
|Last Verified:||July 2015|
Connective Tissue Diseases