Cutaneous Lupus Erythematosus Clinical Trial
Official title:
Single Blind, Controlled, Single-Center Study of Laser Treatment in Cutaneous Lupus Erythematosus
The purpose of using the 595 nm Vbeam Perfecta™ flashlamp-excited, pulsed dye laser in this study is to help improve study patients' skin disease. Cutaneous lupus erythematosus (CLE) often presents with disfiguring vascular lesions which are frequently difficult to treat with the available therapeutic measures, such as photoprotection, topical steroids, and antimalarials. Laser therapy provides an alternative treatment option for CLE patients. Although there has been documented experience with laser treatment in CLE patients, no study comparing treated lesions to the natural course of the disease has been conducted.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 2010 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Cutaneous lupus erythematosus confirmed by histological analysis - Fitzpatrick I-III skin type (very fair, fair, or medium skin) - Stable disease and in relatively good health - Presence of two skin lesions that are suitable for laser treatment - Written informed consent available prior to any screening procedures - Female patients must be willing to use the appropriate birth control measures that will prevent pregnancy from the time of signing informed consent through 60 days after their last laser treatment Exclusion Criteria: - Clinically significant dyspigmentation - History of isotretinoin use, phenol peels, filler injections (collagen, fat), dermabrasion within the past 3 years - History of hypertrophic scarring - History of photosensitivity in the 585-600 nm wavelength region - History of seizure disorders triggered by light - Pregnancy and lactation - Fitzpatrick V or VI skin type (moderately pigmented brown, or markedly pigmented black skin) - Patients receiving anticoagulants and/or medication for which sunlight exposure is a contraindication - Known malignancy or prior malignancy, other than non-melanoma skin cancer |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania, Department of Dermatology | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Baniandrés O, Boixeda P, Belmar P, Pérez A. Treatment of lupus erythematosus with pulsed dye laser. Lasers Surg Med. 2003;32(4):327-30. — View Citation
Núñez M, Boixeda P, Miralles ES, de Misa RF, Ledo A. Pulsed dye laser treatment of telangiectatic chronic erythema of cutaneous lupus erythematosus. Arch Dermatol. 1996 Mar;132(3):354-5. — View Citation
Raulin C, Schmidt C, Hellwig S. Cutaneous lupus erythematosus-treatment with pulsed dye laser. Br J Dermatol. 1999 Dec;141(6):1046-50. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of laser treated CLE skin lesions with a non-treated control CLE lesion of the same patient evaluated by the CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) and the M-CLASI (Modified CLASI). | One year | No | |
Secondary | Pain and itch relief compared to baseline and between the treated and untreated lesion | One Year | No | |
Secondary | Reduction or increase in CLASI and MCLASI scores compared to baseline, and adverse events | One year | Yes |
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