Laser Treatment of Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

Official title:

Laser Treatment of Basal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936932
• Other study ID #: BCCCIP001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: August 20, 2022

Study information

• Verified date: December 2022
• Source: Sciton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laser treatment of Basal cell carcinoma

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Device:
• 1064 nm long-pulse Nd:YAG laser
BCC lesion will be treated with long-pulse 1064 laser
• 1064 nm long-pulse Nd:YAG laser
BCC lesion will be treated with long-pulse 1064 laser

Locations

Country	Name	City	State
United States	Skin & Allergy Center	Spring Hill	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Sciton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cosmetic outcome	Cosmetic outcome and any adverse effects of the laser treatment will be assessed	1 year