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

NCT00523588 | Completed Phase 2 DMC

• 1 other identifier: 805209
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cutaneous lupus erythematosus; Pulsed dye laser

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Pain and itch relief compared to baseline and between the treated and untreated lesion

  One Year

• Reduction or increase in CLASI and MCLASI scores compared to baseline, and adverse events

  One year

Interventions

laser treatment (Candela Vbeam Perfecta™) PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, Department of Dermatology

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Nunez 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. No abstract available.

  PMID: 8607651 BACKGROUND

• Raulin C, Schmidt C, Hellwig S. Cutaneous lupus erythematosus-treatment with pulsed dye laser. Br J Dermatol. 1999 Dec;141(6):1046-50. doi: 10.1046/j.1365-2133.1999.03203.x.

  PMID: 10606850 BACKGROUND

• Baniandres O, Boixeda P, Belmar P, Perez A. Treatment of lupus erythematosus with pulsed dye laser. Lasers Surg Med. 2003;32(4):327-30. doi: 10.1002/lsm.10169.

  PMID: 12696102 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Victoria P Werth, M.D.

  University of Pennsylvania, Department of Dermatology and Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: March 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: January 1, 2010
• Last Updated: June 25, 2010

Record last verified: 2010-01

Locations

US (1)