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Treatment of Cutaneous Lupus Erythematosus (CLE) With the 595 nm Flashlamp Pulsed Dye Laser

NCT00523588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-06-25

No results posted yet for this study

Summary

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.

Conditions

  • Cutaneous Lupus Erythematosus

Interventions

PROCEDURE

laser treatment (Candela Vbeam Perfecta™)

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.

Sponsors & Collaborators

Principal Investigators

  • Victoria P Werth, M.D. · University of Pennsylvania, Department of Dermatology and Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-02-28
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00523588 on ClinicalTrials.gov