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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129428
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Michael Goldfarb, University of Michigan

Tracking Information
First Submitted Date  ICMJE August 9, 2005
First Posted Date  ICMJE August 11, 2005
Last Update Posted Date May 1, 2015
Study Start Date  ICMJE August 2002
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2007)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2005)
Improvement in appearance of keloids (hypertrophic scars), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare, and related conditions with altered dermal matrix.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2007)
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2005)
  • 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.
  • Photographs will also be taken.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix
Official Title  ICMJE The Effectiveness of UVB Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Keloid
  • Scleroderma, Localized
  • Acne Keloidalis
  • Scars
  • Granuloma Annulare
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Procedure: UVB Irradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2015)
33
Original Enrollment  ICMJE
 (submitted: August 9, 2005)
50
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129428
Other Study ID Numbers  ICMJE Derm 447
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Goldfarb, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: John J Voorhees, MD University of Michigan
PRS Account University of Michigan
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP