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

Intervention: UVB Irradiation (Procedure)

Phase: Phase 1/Phase 2

Enrollment status: Recruiting

Sponsor: University of Michigan

Principal investigator(s) or official(s):
John J Voorhees, MD, Study Chair, Affiliation: University of Michigan

This research study will evaluate the effectiveness of high dose UVB light therapy in the treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare or related conditions.

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

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

Primary outcome: Improvement in appearance of keloids (hypertrophic scars), scleroderma, acne keloidalis nuchae,old burn scars, granuloma annulare, and related conditions with altered dermal matrix (Time Frame: Subjects will be evaluated at weeks 1, 2, 4, and then at monthly intervals until the end of the study.)

Secondary outcome:
Assays to be performed on biopsy specimens may include any or all of the following assays: in situ hybridization, immunohistologic analysis, in situ zymography, radioimmunoassay, and Western blot analysis (Time Frame: Assays will be performed after specimen collection)

Photographs will also be taken. (Time Frame: At baseline and at end of the study.)

Detailed description: 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.

However, UVA1 is unable to penetrate pigmented skin at an effective level to activate matrix metalloproteinases (MMPs). The investigators' preliminary data show that high dose UVB (160 mJ/cm2) will penetrate pigmented skin and activate the cellular pathways necessary to stimulate MMPs. They postulate, therefore, that in pigmented skin, higher than usual UVB doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen via activation of MMP pathways.

The purpose of this research project is to study the effectiveness of high dose UVB (290-320nm at up to 320mJ/cm2) irradiation for the treatment of skin conditions with altered dermal matrix in patients with increased skin pigmentation. These disorders include but are not limited to keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, and granuloma annulare. Up to fifty patients with one of these diagnoses or related conditions will receive UVB irradiation up to 5 times per week, for 16 weeks.

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

Criteria:

Inclusion Criteria:

- In good general health and between 10-80 years of age.

- Willing and able to receive UVB, as directed in the protocol; make evaluation visits;

follow protocol restrictions; and sign a written, witnessed, informed consent form.

- Have a clinical diagnosis of keloid, scleroderma, old burn scars, granuloma annulare,

or acne keloidalis nuchae.

- No disease states or physical conditions that would impair evaluation of the test

site

- Must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able

to attend all of the scheduled appointments during the study.

Exclusion Criteria:

- Have a history of photosensitivity (development of hives or bumps with exposure to

light) or experience hypersensitivity in a UVB photo-provocation test.

- Have participated in another investigational study in the past 4 weeks, taken oral

therapy for skin condition, or on photosensitizing medications.

- Pregnant, nursing, or planning to become pregnant during the study.

University of Michigan Department of Dermatology, Ann Arbor, Michigan 48109, United States; Recruiting
Ted A Hamilton, MS, Email: tedah@umich.edu
Sewon Kang, MD, Email: swkang@umich.edu
Sewon Kang, MD, Principal Investigator

Start date: August 2002
End date: August 2010
Last updated: June 2, 2008

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