Condition(s) treated: Keloid; Scleroderma; Scars; Granuloma Annulare; Acne Keloidalis Nuchae

Intervention: German manufactured UVA1 emitting light system (Device)

Enrollment status: Recruiting

Sponsor: University of Michigan

Principal investigator(s) or official(s):
Sewon Kang, MD, Principal Investigator, Affiliation: University of Michigan hospital

Overall contact:
Ted A Hamilton, MS, Email: tedah@umich.edu

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.

Official title: The Effectiveness of UVA1 Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Measurement of plaque thickness, increase in mobility, plaque hardness (Time Frame: 16 weeks)

Secondary outcome: Analysis of collagen levels, mmp induction (Time Frame: 16 weeks)

Detailed description: 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.

Minimum eligible age: 10 Years. Maximum eligible age: 80 Years. Eligible gender(s): Both.

Criteria:

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.

Ted A Hamilton, MS, Email: tedah@umich.edu

University of Michigan Department of Dermatology, Ann Arbor, Michigan 48109-0314, United States; Recruiting
Ted A Hamilton, MS, Email: tedah@umich.edu

Start date: January 1997
End date: July 2010
Last updated: June 2, 2008

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