Pilot Study of PDL to Treat BCC and SCCIS

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Morphological and Microscopic Findings Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Pathological Conditions, Signs and Symptoms Squamous Cell Carcinoma in Situ Squamous Intraepithelial Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDL Treatment

Procedure

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

Primary outcomes

Tumor Clearance

Time frame: 21 to 36 days after the treatment

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).

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study 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

Acronym: PDLNMSC

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Nov 23, 2010
Registry last updated: Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed