Basal Cell CarcinomaNCT04744935
Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
A study testing 1064 nm long-pulse Nd:YAG laser in people with Basal Cell Carcinoma and Superficial Basal Cell Carcinoma, run by Christopher Zachary at 1 site in United States.
Trial summary
Optical coherence tomography guided laser treatment of basal cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
- What is being tested?
- 1064 nm long-pulse Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 20 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI Health Dermatology Clinic
Irvine, California, 92617
About this study
Optical coherence tomography guided laser treatment of basal cell carcinoma
Read the detailed 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.
- Being tested
- 1064 nm long-pulse Nd:YAG laser
- Keywords
- Basal cell carcinoma, Superficial basal cell carcinoma, Nodular basal cell carcinoma, Optical coherence tomography, OCT, Laser
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1064 nm long-pulse Nd:YAG laserDevice
BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: 1064 nm long-pulse Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start13 Jan 2021
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Zachary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Zachary, University of California, Irvine
- Investigators
- Christopher Zachary, MBBS FRCP, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744935
- Sponsor's protocol ID
- 20205664
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2021
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04744935
- Acronym / sponsor ID
- 20205664
- Keywords
- Basal cell carcinoma, Superficial basal cell carcinoma, Nodular basal cell carcinoma, Optical coherence tomography, OCT, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Christopher ZacharyUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Posted 21 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optical coherence tomography guided laser treatment of basal cell carcinoma
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Device: 1064 nm long-pulse Nd:YAG laser1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec |
| Slow | Active comparator | Device: 1064 nm long-pulse Nd:YAG laser1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1064 nm long-pulse Nd:YAG laserBCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera. | Device | Slow, Standard |
Primary outcome
Complete Histological Clearance of BCC Lesion
Time frame: 1 year
Those whose lesion is not in a cosmetically sensitive area will undergo a skin biopsy for histological confirmation of OCT results.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Basal Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Zachary, MBBS FRCP principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1064 nm long-pulse Nd:YAG laser in people with Basal Cell Carcinoma and Superficial Basal Cell Carcinoma, run by Christopher Zachary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Histological Clearance of BCC Lesion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.