NCT04744935

Brief Summary

Optical coherence tomography guided laser treatment of basal cell carcinoma

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2021Feb 2027

Study Start

First participant enrolled

January 13, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

6.1 years

First QC Date

February 4, 2021

Last Update Submit

March 19, 2026

Conditions

Nodular Basal Cell CarcinomaBasal Cell CarcinomaSuperficial Basal Cell Carcinoma

Keywords

Basal cell carcinomaSuperficial basal cell carcinomaNodular basal cell carcinomaOptical coherence tomographyOCTLaser

Outcome Measures

Primary Outcomes (1)

  • Complete histological 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

Study Arms (2)

Standard

ACTIVE COMPARATOR

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

Slow

ACTIVE COMPARATOR

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

Interventions

1064 nm long-pulse Nd:YAG laserDEVICE

BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.

SlowStandard

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCI Health Dermatology Clinic

Irvine, California, 92617, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Christopher Zachary, MBBS FRCP

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of the UCI Department of Dermatology

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

January 13, 2021

Primary Completion (Estimated)

February 17, 2027

Study Completion (Estimated)

February 17, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)