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Laser Treatment of Basal Cell Carcinoma

Primary Purpose

Basal Cell Carcinoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

1064 nm long-pulse Nd:YAG laser

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Superficial Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects 18 years of age or older
Lesion is biopsy-proven superficial BCC <= 2.0 cm in largest diameter
BCC is on trunk or extremities
Seeks and is scheduled for treatment of BCC
Willing to have photographs taken of the treatment area
Ability to understand and the willingness to sign a written informed consent document
Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria:

Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
Pregnancy
Subjects unable to follow-up for the full 12-months
Subjects not willing to have biopsy taken from the treatment area
Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome

Sites / Locations

Skin & Allergy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Standard

Slow

Arm Description

1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec

1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec

Outcomes

Primary Outcome Measures

Complete clearance of BCC

Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance

Secondary Outcome Measures

Cosmetic outcome

Cosmetic outcome and any adverse effects of the laser treatment will be assessed

Full Information

NCT ID

NCT04936932

First Posted

June 21, 2021

Last Updated

December 6, 2022

Sponsor

Sciton

1. Study Identification

Unique Protocol Identification Number

NCT04936932

Brief Title

Laser Treatment of Basal Cell Carcinoma

Official Title

Laser Treatment of Basal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

August 20, 2022 (Actual)

Study Completion Date

August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sciton

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Laser treatment of Basal cell carcinoma

Detailed Description

The purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (BCC) with laser technology. The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basal Cell Carcinoma

Keywords

Superficial Basal Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard

Arm Type

Active Comparator

Arm Description

1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec

Arm Title

Slow

Arm Type

Active Comparator

Arm Description

1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec

Intervention Type

Device

Intervention Name(s)

1064 nm long-pulse Nd:YAG laser

Intervention Description

BCC lesion will be treated with long-pulse 1064 laser

Intervention Type

Device

Intervention Name(s)

1064 nm long-pulse Nd:YAG laser

Intervention Description

BCC lesion will be treated with long-pulse 1064 laser

Primary Outcome Measure Information:

Title

Complete clearance of BCC

Description

Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Cosmetic outcome

Description

Cosmetic outcome and any adverse effects of the laser treatment will be assessed

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects 18 years of age or older Lesion is biopsy-proven superficial BCC <= 2.0 cm in largest diameter BCC is on trunk or extremities Seeks and is scheduled for treatment of BCC Willing to have photographs taken of the treatment area Ability to understand and the willingness to sign a written informed consent document Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions Exclusion Criteria: Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases. Pregnancy Subjects unable to follow-up for the full 12-months Subjects not willing to have biopsy taken from the treatment area Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chris Robb, MD

Organizational Affiliation

Skin & Allergy Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skin & Allergy Center

City

Spring Hill

State/Province

Tennessee

ZIP/Postal Code

37174

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Laser Treatment of Basal Cell Carcinoma

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