UVA1 Light for Treatment of Scleroderma and Similar Conditions

NCT ID: NCT00476801

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2004-02-29

Brief Summary

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.

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/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.

Conditions

Scleroderma; Keloids; Other Fibrosing Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

German manufactured UVA1 light emitting device

Intervention Type: DEVICE

The UVA1 dose will be up to 130 J/cm2.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

German manufactured UVA1 light emitting device

The UVA1 dose will be up to 130 J/cm2.

Intervention Type: DEVICE

Eligibility 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.
• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

University of Michigan Department of Dermatology

Principal Investigators

Sewon Kang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan hospital

Locations

University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Derm 438

Identifier Type: -

Identifier Source: org_study_id