Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix
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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 |
- 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 ]
- 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) |
-
Procedure: UVB Irradiation
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 |
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| United States, Michigan | |
| University of Michigan Department of Dermatology | |
| Ann Arbor, Michigan, United States, 48109 | |
| 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:
|
Acne Vulgaris Acne Keloid Scleroderma, Systemic Scleroderma, Diffuse Granuloma Keloid Scleroderma, Localized Skin Diseases Granuloma Annulare Cicatrix Acneiform Eruptions |
Facial Dermatoses Sebaceous Gland Diseases Collagen Diseases Connective Tissue Diseases Folliculitis Hair Diseases Lymphoproliferative Disorders Lymphatic Diseases Pathologic Processes Fibrosis Necrobiotic Disorders |
ClinicalTrials.gov processed this record on May 21, 2013