UVA1 Light for Scleroderma and Similar Conditions
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Keloid Scleroderma Scars Granuloma Annulare Acne Keloidalis Nuchae |
Device: German manufactured UVA1 emitting light system |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Measurement of plaque thickness, increase in mobility, plaque hardness [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Analysis of collagen levels, mmp induction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 1997 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
-
Device: German manufactured UVA1 emitting light system
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.
Eligibility| Ages Eligible for Study: | 10 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00476697 History of Changes |
| Other Study ID Numbers: | Derm 364 |
| Study First Received: | May 18, 2007 |
| Last Updated: | October 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
UVA1 scleroderma keloids morphea light therapy |
Additional relevant MeSH terms:
|
Acne Keloid Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Granuloma Keloid Granuloma Annulare Cicatrix Collagen Diseases Connective Tissue Diseases |
Acneiform Eruptions Skin Diseases Facial Dermatoses Folliculitis Hair Diseases Lymphoproliferative Disorders Lymphatic Diseases Pathologic Processes Fibrosis Necrobiotic Disorders |
ClinicalTrials.gov processed this record on June 18, 2013