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Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix

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ClinicalTrials.gov Identifier: NCT00129428
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : May 1, 2015
Information provided by (Responsible Party):
Michael Goldfarb, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Keloid Scleroderma, Localized Acne Keloidalis Scars Granuloma Annulare Procedure: UVB Irradiation Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of UVB Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study
Study Start Date : August 2002
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: UVB Irradiation
A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.
Procedure: UVB Irradiation
A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Photographs will also be taken. [ Time Frame: At baseline and at end of the study. ]

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129428

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United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Study Chair: John J Voorhees, MD University of Michigan
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Responsible Party: Michael Goldfarb, Clinical Lecturer in Dermatology, Medical School Department, University of Michigan
ClinicalTrials.gov Identifier: NCT00129428    
Other Study ID Numbers: Derm 447
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Michael Goldfarb, University of Michigan:
acne keloidalis nuchae
granuloma annulare
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Skin Diseases
Acne Keloid
Granuloma Annulare
Scleroderma, Localized
Connective Tissue Diseases
Collagen Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Acneiform Eruptions
Hair Diseases
Necrobiotic Disorders