Pilot Study of PDL to Treat BCC and SCCIS

NCT ID: NCT01245972

Last Updated: 2019-09-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Basal Cell Carcinoma Squamous Cell Carcinoma in Situ

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

No treatment administered

Group Type NO_INTERVENTION

No interventions assigned to this group

PDL Setting 1

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

Group Type EXPERIMENTAL

PDL Treatment

Intervention Type PROCEDURE

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

PDL Setting 2

PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses

Group Type EXPERIMENTAL

PDL Treatment

Intervention Type PROCEDURE

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

Interventions

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PDL Treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Dr. Shang I. Brian Jiang

Clinical Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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S. I. Brian Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Medical Center, Division of Dermatology

Other Identifiers

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HRPP-101001

Identifier Type: -

Identifier Source: org_study_id

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