A Phase 2 interventional study of laser treatment (Candela Vbeam Perfecta™) in Cutaneous Lupus Erythematosus, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-25.
Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment
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.
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This laser has an adjustable pulse duration (0.45-40 ms), fixed wavelength 595 nm, spot size (3 mm, 5 mm, 7 mm, and 10 mm), and incident fluence range of 10-40 J/cm2. The laser is also equipped with a dynamic cooling device (DCD) (FDA cleared under K001589) that delivers cryogen (R-134a) from a small nozzle positioned 4 cm above the skin at an angle of approximately 70 degrees with respect to the skin surface. All patients will be treated with the laser device on which the varying cooling device parameters will be selected based on the clinical judgment of the treating physician. Factors used in this decision include patient age, skin type and epidermal pigmentation, size and depth of vessels, color of lesions, anatomic location, etc. In all instances, a test-dose in an inconspicuous location on the skin will be conducted prior to the first treatment.
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).
Time frame: One year
Pain and itch relief compared to baseline and between the treated and untreated lesion
Time frame: One Year
Reduction or increase in CLASI and MCLASI scores compared to baseline, and adverse events
Time frame: One year
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic→
University of Pennsylvania