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Cutaneous Lupus ErythematosusPhase 2NCT00523588

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

A Phase 2 study testing laser treatment (Candela Vbeam Perfecta™) in people with Cutaneous Lupus Erythematosus, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cutaneous Lupus Erythematosus
What is being tested?
laser treatment (Candela Vbeam Perfecta™)
Type of treatment
Surgery or procedure
How many people
10 participants
Where
1 siteUnited States
Study dates
Mar 2007to Jan 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania, Department of Dermatology

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
laser treatment (Candela Vbeam Perfecta™)
Keywords
Cutaneous lupus erythematosus, Pulsed dye laser
Medical subject headings
Lupus Erythematosus, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laser treatment (Candela Vbeam Perfecta™)Procedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: One year

Secondary outcomes (2)

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

    Measured: One Year

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

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionFeb 2009
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00523588
Sponsor's protocol ID
805209
Status last verified
Jan 2010
First submitted
30 Aug 2007
Last updated
25 Jun 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 8607651

  • 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.

    PubMed 10606850

  • 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.

    PubMed 12696102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing laser treatment (Candela Vbeam Perfecta™) in people with Cutaneous Lupus Erythematosus, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00523588, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2010.

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