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| Tracking Information | |||||
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| First Received Date ICMJE | August 9, 2005 | ||||
| Last Updated Date | July 29, 2009 | ||||
| Start Date ICMJE | August 2002 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 | Complete list of historical versions of study NCT00129428 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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. |
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| 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 Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: UVB Irradiation | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | January 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00129428 | ||||
| Responsible Party | Sewon Kang, MD, Professor and Director of Clinical Pharmacology, University of Michigan Department of Dermatology | ||||
| Study ID Numbers ICMJE | Derm 447 | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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