Pilot Study of PDL to Treat BCC and SCCIS

Basal Cell Carcinoma Clinical Trial

— PDLNMSC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245972
• Other study ID #: HRPP-101001
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma in Situ

Intervention

Procedure:
• PDL Treatment
Pulsed-dye laser (PDL) treatment at one of two settings.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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