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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00523588 |
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.
Condition | Intervention | Phase |
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Cutaneous Lupus Erythematosus |
Procedure: laser treatment (Candela Vbeam Perfecta™) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment |
Official Title: | Single Blind, Controlled, Single-Center Study of Laser Treatment in Cutaneous Lupus Erythematosus |
Estimated Enrollment: | 10 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
The Candela Vbeam PerfectaTM is an FDA approved 595nm Flashlamp Pulsed Dye Laser (PDL) that is being used for the treatment of benign skin lesions. The purpose of using the PDL in this study is to help improve study patients' skin disease. Cutaneous Lupus Erythematosus often starts with damaging skin lesions which are frequently difficult to treat with the available therapeutic measures. This study will use a flashlamp PDL to compare treated cutaneous lesions and non-treated lesions. We will look at factors such as the degree of erythema (redness of the skin), scale and hypertrophy (increase in size of skin), scarring and dyspigmentation (abnormality in the formation or distribution of skin coloration) and make a summary score of these factors.
It is important to note that this device currently is being used to treat patients with skin lesions in the Department of Dermatology at the University of Pennsylvania, where this study will be done. Although the PDL has been used to treat other patients, its use in this study is experimental.
The PDL is considered to be the laser of choice for vascular lesions, because at wavelengths of 585-595 nm, the laser is known to produce excellent clinical results at minimal risk to patients. The laser has been used successfully in the treatment of port-wine stains in children as young as 1 month of age. The PDL is designed to deliver an intense but gentle burst of laser light to the skin. The light is absorbed by the blood vessels in the vascular lesion, while leaving the surrounding tissue undamaged. The PDL has been used clinically for the treatment of cutaneous lesions in childhood port-wine stains, childhood proliferative angiomas, facial telangiectasias, poikiloderma of Civatte, nevus flammeus, capillary hemangiomas, scars, verrucae, and lupus erythematosus. Several studies are known to have used the 585-595nm PDL to treat cutaneous lupus erythematosus lesions.
During a period of 5 months, study patients will receive 3-5 treatments to one skin lesion with the pulsed dye laser. Clinical follow-up examinations include photographs, clinical assessments by a blinded physician, and pain and itch scales by the study patient. The study requires a total of one year commitment per study patient.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joyce Okawa, R.N. | 215-898-0168 | joyce.okawa@uphs.upenn.edu |
United States, Pennsylvania | |
University of Pennsylvania, Department of Dermatology | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Principal Investigator: Victoria P. Werth, MD |
Principal Investigator: | Victoria P Werth, M.D. | University of Pennsylvania, Department of Dermatology and Internal Medicine |
Responsible Party: | University of Pennsylvania School of Medicine ( Dr. Victoria Werth/Professor of Medicine and Dermatology ) |
Study ID Numbers: | 805209 |
Study First Received: | August 30, 2007 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00523588 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Cutaneous lupus erythematosus Pulsed dye laser |
Cutaneous Lupus Erythematosus Autoimmune Diseases Skin Diseases Lupus Erythematosus, Systemic |
Lupus Lupus Erythematosus, Cutaneous Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Skin Diseases |
Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous Connective Tissue Diseases |