Laser Treatment of Basal Cell Carcinoma

• Sponsor: Sciton (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04936932
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Laser treatment of Basal cell carcinoma

Condition or Disease	Intervention/Treatment	Phase
Basal Cell Carcinoma	Device: 1064 nm long-pulse Nd:YAG laser; Device: 1064 nm long-pulse Nd:YAG laser	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Laser Treatment of Basal Cell Carcinoma
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Sep 15, 2022
• Anticipated Study Completion Date: Jan 29, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Complete clearance of BCC [1 year]

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

Secondary Outcome Measures

1. Cosmetic outcome [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skin & Allergy Center	Spring Hill	Tennessee	United States	37174

Sponsors and Collaborators

• Sciton

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sciton
• ClinicalTrials.gov Identifier: NCT04936932
• Other Study ID Numbers: BCCCIP001
• First Posted: Jun 23, 2021
• Last Update Posted: Nov 8, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Sciton: Superficial Basal Cell Carcinoma
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Basal Cell

Study Results

No Results Posted as of Nov 8, 2021