Laser Treatment of Basal Cell Carcinoma

Not Applicable

Completed

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT04936932
• Lead Sponsor: Sciton

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.

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-23
• Study Start: 2021-11-01
• Primary Completion: 2022-08-20
• Study Completion: 2022-08-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cosmetic outcome	1 year	Cosmetic outcome and any adverse effects of the laser treatment will be assessed

Trial Locations

Locations (1)

Skin & Allergy Center; 🇺🇸 Spring Hill, Tennessee, United States