UVA1 Light for Treatment of Scleroderma and Similar Conditions
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 10 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | July 2001 |
| End Date: | February 2004 |
The Effectiveness Of UVA1 Irradiation In The Treatment Of Skin Conditions With Altered Dermal Matrix: A Controlled, Cross-Over Study
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.
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.
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.
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.
- 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.
Exclusion Criteria:
- 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.
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