Pilot Study of PDL to Treat BCC and SCCIS

NCT01245972 | Completed Results

• 1 other identifier: HRPP-101001
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Basal Cell Carcinoma; Squamous Cell Carcinoma in Situ

Keywords

pulsed dye laser; PDL; basal cell carcinoma; squamous cell carcinoma; BCC; SCC; 594nM laser

Outcome Measures

Primary Outcomes (1)

• Tumor Clearance

  Review of the pathology report showing whether there was residual tumor or not. If there was no residual tumor in the pathology report from the confirmatory excision, the laser treatment was considered successful (tumor clearance).

  21 to 36 days after the treatment

Study Arms (3)

Control

NO INTERVENTION

No treatment administered

PDL Setting 1

EXPERIMENTAL

PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes

Procedure: PDL Treatment

PDL Setting 2

EXPERIMENTAL

PDL 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

Interventions

PDL Treatment PROCEDURE

Pulsed-dye laser (PDL) treatment at one of two settings.

PDL Setting 1; PDL Setting 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell; Squamous Intraepithelial Lesions; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Neoplasms, Squamous Cell

Results Point of Contact

• Title: S. Brian Jiang
• Organization: ucsdmed

s2jiang@ucsd.edu

8586571663

Study Officials

• S. I. Brian Jiang, MD

  UCSD Medical Center, Division of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Dermatology

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-08