NCT04936932CompletedNot Applicable
Laser Treatment of Basal Cell Carcinoma
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sciton
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Complete clearance of BCC
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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
Outcomes
Primary Outcomes
Complete clearance of BCC
Time Frame: 1 year
Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance
Secondary Outcomes
- Cosmetic outcome(1 year)
Investigators
Study Sites (2)
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