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

June 24, 2010 updated by: University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain and itch relief compared to baseline and between the treated and untreated lesion
Time Frame: One Year
One Year
Reduction or increase in CLASI and MCLASI scores compared to baseline, and adverse events
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

June 25, 2010

Last Update Submitted That Met QC Criteria

June 24, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 805209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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