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Pilot Study of PDL to Treat BCC and SCCIS (PDLNMSC)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01245972
First received: November 22, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

This is a research study to find out more about the use of the pulsed dye laser in the treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not invaded deep into the skin. The purpose of this study is to determine whether the use of the pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage squamous cell carcinoma.

Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that have a prominent blood vessel component. It has been used to treat broken blood vessels on the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions with a prominent vascular component.


Condition Intervention
Basal Cell Carcinoma
Squamous Cell Carcinoma in Situ
 Procedure: PDL Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Examine the Effectiveness of 595nM Pulsed Dye Lasers in the Treatment of Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Tumor regression [ Time Frame: 2-6 wks ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: August 2010
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Setting 1
Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes
 Procedure: PDL Treatment
Pulsed-dye laser treatment at one of two settings.
Experimental: Setting 2
Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses
 Procedure: PDL Treatment
Pulsed-dye laser treatment at one of two settings.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring surgical excision (conventional or Mohs) for biopsy-proven basal cell carcinoma and biopsy-proven squamous cell carcinoma in situ that is clinically present at the pre-operative visit and measures greater than 0.4cm and less than 3cm in size.
  • Lesions in the Trunk, Extremities, and Scalp
  • Presence of clinically identifiable residual tumor.
  • Patients, males and females, aged 18-90 years.
  • Willing to participate.
  • Able to give informed consent.

Exclusion Criteria:

  • Age younger than 18 years
  • Location of lesion not in the Trunk, Extremities, and Scalp
  • Fitzpatrick skin type V or VI.
  • Prior history of known light sensitivity.
  • Pregnancy
  • Cognitive Impairment
  • Prisoner
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245972

Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: S. I. Brian Jiang, MD UCSD Medical Center, Division of Dermatology
  More Information

No publications provided

Responsible Party: Shang I. Brian Jiang, MD, UCSD Medical Center, Division of Dermatology
ClinicalTrials.gov Identifier: NCT01245972     History of Changes
Other Study ID Numbers: HRPP-101001
Study First Received: November 22, 2010
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
pulsed dye laser
PDL
basal cell carcinoma
squamous cell carcinoma
 BCC
SCC
594nM laser

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on May 22, 2013