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

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00129428
First received: August 9, 2005
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Keloid
Scleroderma, Localized
Acne Keloidalis
Scars
Granuloma Annulare
Procedure: UVB Irradiation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Photographs will also be taken. [ Time Frame: At baseline and at end of the study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2002
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129428

Locations
United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Study Chair: John J Voorhees, MD University of Michigan
  More Information

No publications provided

Responsible Party: Sewon Kang, MD, Professor and Director of Clinical Pharmacology, University of Michigan Department of Dermatology
ClinicalTrials.gov Identifier: NCT00129428     History of Changes
Other Study ID Numbers: Derm 447
Study First Received: August 9, 2005
Last Updated: July 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
UVB
keloid
scleroderma
acne keloidalis nuchae
scars
granuloma annulare

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Granuloma
Skin Diseases
Acne Keloid
Granuloma Annulare
Scleroderma, Localized
Connective Tissue Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Keloid
Collagen Diseases
Acneiform Eruptions
Facial Dermatoses
Folliculitis
Hair Diseases
Necrobiotic Disorders

ClinicalTrials.gov processed this record on September 22, 2014