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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04744935
Other study ID # 20205664
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 13, 2021
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source University of California, Irvine
Contact Feben Messele
Phone 949-824-5515
Email fmessele@hs.uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Optical coherence tomography guided laser treatment of basal cell carcinoma


Description:

The purpose of this pilot study is to examine the treatment basal cell carcinoma (BCC) with laser technology under the guidance of optical coherence tomography imaging (OCT). 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. Laser treatment of BCC has limited precedent in the literature, but the addition of OCT has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. We propose to use OCT imaging to guide the laser treatment to achieve optimal efficacy with minimized side-effects.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative - Ages 18 and older - Seeks and is scheduled for treatment of a BCC previously confirmed with biopsy Exclusion Criteria: Any of the following will exclude participation in the study: - Inability to understand and/or carry out instructions - Patients with a BCC lesion that requires excision. This would include relatively large lesions (>2.5 cm diameter), lesions that penetrate deep into the skin beyond the depth of the OCT image capture, high risk lesions as defined by the American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases. - Patients with periocular BCCs which might expose the patient to risk of damage to eyes from the laser. - BCCs on legs due to their tendency towards poor wound healing. - Pregnancy - Patients unable to follow-up for the full 12 months.

Study Design


Intervention

Device:
1064 nm long-pulse Nd:YAG laser
BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.

Locations

Country Name City State
United States UCI Health Gottschalk Medical Plaza Irvine California

Sponsors (1)

Lead Sponsor Collaborator
Christopher Zachary

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete clearance of BCC lesion Those whose lesion is not in a cosmetically sensitive area will undergo a skin biopsy for histological confirmation of OCT results. 1 year
Secondary Cosmetic outcome We assess cosmetic outcome and any adverse effects of the laser treatment as a result of the laser treatment, rated on a 0-4 Likert scaleworst cosmetic outcome and 4 resembling normal skin, upon follow-up of treatment. 1 year
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