Laser Treatment of Basal Cell Carcinoma

Laser treatment of Basal cell carcinoma

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Device: 1064 nm long-pulse Nd:YAG laser

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Spring Hill, Tennessee, United States, 37174
      • Skin & Allergy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Pregnancy
3. Subjects unable to follow-up for the full 12-months
4. Subjects not willing to have biopsy taken from the treatment area
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; 1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec	Device: 1064 nm long-pulse Nd:YAG laser; BCC lesion will be treated with long-pulse 1064 laser
Active Comparator: Slow; 1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec	Device: 1064 nm long-pulse Nd:YAG laser; BCC lesion will be treated with long-pulse 1064 laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete clearance of BCC	Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic outcome	Cosmetic outcome and any adverse effects of the laser treatment will be assessed	1 year

Collaborators and Investigators

• Sponsor: Sciton
• Investigators: Principal Investigator: Chris Robb, MD, Skin & Allergy Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): August 20, 2022
• Study Completion (Actual): August 20, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Superficial Basal Cell Carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: BCCCIP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes