UVA1 Light for Scleroderma and Similar Conditions

• ClinicalTrials.gov Identifier: NCT00476697
• Recruitment Status: Terminated
• First Posted: May 22, 2007
• Last Update Posted: July 27, 2015
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Yolanda Rosi Helfrich, University of Michigan

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Keloid; Scleroderma; Scars; Granuloma Annulare; Acne Keloidalis Nuchae	Device: German manufactured UVA1 emitting light system	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: January 1997
• Actual Primary Completion Date: July 2003
• Actual Study Completion Date: July 2003

Arms and Interventions

Arm	Intervention/treatment
Experimental: UVA1 Irradiation; UVA1 irradiaton up to 5 times per week, for up to 16 weeks using German manufactured UVA1 emitting light system. UVA1 dose will be applied with up to 130 J/cm2.	Device: German manufactured UVA1 emitting light system; The dose and scheduling of irradiation is as follows: Up to 130J/cm2 from a UVA1 Sellamed irradiation device with irradiations up to 5 times per week.

Outcome Measures

Primary Outcome Measures :

1. Measurement of plaque thickness, increase in mobility, plaque hardness [ Time Frame: 16 weeks ]

Secondary Outcome Measures :

1. Analysis of collagen levels, mmp induction [ Time Frame: 16 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Michigan

University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States, 48109-0314

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Yolanda Helfrich, MD; University of Michigan hospital

More Information

• Responsible Party: Yolanda Rosi Helfrich, Director Program for Clinical Research In Dermatology, University of Michigan
• ClinicalTrials.gov Identifier: NCT00476697
• Other Study ID Numbers: Derm 364
• First Posted: May 22, 2007
• Last Update Posted: July 27, 2015
• Last Verified: July 2015

Keywords provided by Yolanda Rosi Helfrich, University of Michigan:

UVA1; scleroderma; keloids; morphea; light therapy

Additional relevant MeSH terms:

Granuloma; Scleroderma, Systemic; Scleroderma, Diffuse; Keloid; Granuloma Annulare; Acne Keloid; Connective Tissue Diseases; Skin Diseases; Collagen Diseases; Cicatrix; Fibrosis; Pathologic Processes; Lymphoproliferative Disorders; Lymphatic Diseases; Necrobiotic Disorders; Acneiform Eruptions; Folliculitis; Hair Diseases