Laser Treatment for Basal Cell Carcinoma

Recruiting at 1 trial location

Overseen By Feben Messele

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Large lesions, Deep lesions, High risk, Periocular BCCs, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Optical coherence tomography guided laser treatment of basal cell carcinoma

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is laser treatment for basal cell carcinoma safe?

Research shows that Nd:YAG laser treatment for basal cell carcinoma is generally safe, with studies reporting no significant adverse events and minimal complications. This treatment is well-tolerated and can be performed as a simple outpatient procedure. ^{1 2 3 4 5}

How is Optical Coherence Tomography Guided Laser Treatment different from other treatments for basal cell carcinoma?

This treatment uses a special laser (Nd:YAG laser) combined with imaging technology (optical coherence tomography) to precisely target and treat basal cell carcinoma without surgery, potentially reducing scarring and allowing for better monitoring of the tumor's margins and recurrence. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Optical Coherence Tomography Guided Laser Treatment for basal cell carcinoma?

Research shows that the Nd:YAG laser treatment is effective for basal cell carcinoma, with studies indicating high rates of tumor clearance and minimal side effects. Combining this laser with optical coherence tomography (OCT) may improve treatment by helping to monitor and control tumor margins, potentially reducing recurrence. ^{1 2 3 5 6}

Who Is on the Research Team?

Christopher B Zachary, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of basal cell carcinoma (BCC) who are seeking treatment and can follow instructions or have someone to help them. It's not for pregnant individuals, those unable to commit to a full year of follow-up, patients with BCCs on legs or near the eyes, or cases where the cancer is too large, deep, high-risk or has spread.

Inclusion Criteria

I can understand and follow study instructions or have someone legally authorized to help me.

I am scheduled for treatment of a biopsy-confirmed basal cell carcinoma.

Exclusion Criteria

Inability to understand and/or carry out instructions

I have skin cancer on my legs that might not heal well.

My skin cancer near the eye could be risky for laser treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive optical coherence tomography guided laser treatment for basal cell carcinoma using the long-pulse Nd:YAG 1064nm laser

Varies

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Optical Coherence Tomography Guided Laser Treatment

Trial Overview The study tests how well a type of laser called the 1064 nm long-pulse Nd:YAG can treat basal cell carcinoma when guided by optical coherence tomography—a technique that uses light waves to take cross-section pictures of skin.

How Is the Trial Designed?

Group I: Standard Active Control 1 Intervention

1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec

Group II: Slow Active Control 1 Intervention

1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec

Optical Coherence Tomography Guided Laser Treatment is already approved in European Union, United States for the following indications:

Approved in European Union as Nd:YAG Laser Treatment for:

• Basal Cell Carcinoma

Approved in United States as Nd:YAG Laser Treatment for:

• Basal Cell Carcinoma

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Christopher Zachary

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

In a study involving 10 patients with basal cell carcinoma (BCC), treatment with a pulsed 1064 nm Nd:YAG laser resulted in a 92% rate of complete histologic clearance after just one session, indicating high efficacy for this non-surgical approach.

The laser treatment was well tolerated with no significant adverse events or scarring reported, suggesting it is a safe alternative to traditional surgical methods for treating BCC on the trunk and extremities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1064 nm long-pulsed Nd:YAG laser treatment of basal cell carcinoma. Ortiz, AE., Anderson, RR., Avram, MM.[2015]

The Nd:YAG laser treatment for basal cell carcinoma (BCC) showed a high efficacy, with 70.4% of lesions clearing after just one treatment and complete clinical and subclinical tumor clearance observed in all cases two months after the final treatment.

The study highlighted that factors such as lesion size, specific tumor subtypes, and immunosuppression can affect treatment outcomes, but overall, the recurrence rates were very low, at 1.7% clinically and 4.2% subclinically after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Nd:YAG laser with optical coherence tomography for nonsurgical treatment of basal cell carcinoma. Markowitz, O., Bressler, MY.[2022]

Nd:YAG laser therapy was successfully used to treat 94 skin lesions in 51 patients, demonstrating its effectiveness for various skin tumors, including basal-cell carcinomas and actinic keratosis.

The treatment is advantageous as it can often be completed in a single outpatient procedure, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Nd:YAG laser for treatment of basal-cell carcinomas and some premalignant conditions]. Rubisz-Brzezińska, J., Bendkowski, W.[2007]

In a study involving 33 subjects with biopsy-proven basal cell carcinoma (BCC), the 1064 nm Nd:YAG laser achieved a 90% histologic clearance rate after just one treatment, demonstrating its efficacy as a non-surgical option.

The laser treatment was well tolerated with minimal side effects, such as temporary swelling and redness, and no significant adverse events were reported, making it a safe alternative for patients who are not suitable for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An expanded study of long-pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma. Ortiz, AE., Anderson, RR., DiGiorgio, C., et al.[2019]

CO2 laser vaporization and Nd:YAG laser coagulation are effective treatment options for various malignant skin tumors, including basal cell carcinomas and squamous cell carcinomas, but are not yet standard therapies.

Photodynamic therapy (PDT) is still experimental for treating skin tumors, primarily used for basal cell carcinomas, indicating a need for further clinical studies to establish its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser therapy of skin tumors. Landthaler, M., Szeimies, RM., Hohenleutner, U.[2019]

In a study involving 37 patients with basal cell carcinoma (BCC), treatment with continuous wave Nd:Yag laser-induced hyperthermia resulted in a 97.3% complete cure rate, demonstrating its high efficacy.

The procedure, performed as an outpatient treatment, showed minimal complications and only a 2.7% recurrence rate over a follow-up period of 3-5 years, suggesting it is a safe and effective alternative for BCC management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous-wave Nd:Yag laser hyperthermia: a successful modality in treatment of basal cell carcinoma. El-Tonsy, MH., El-Domyati, MM., El-Sawy, AE., et al.[2007]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

1064 nm long-pulsed Nd:YAG laser treatment of basal cell carcinoma. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Combining Nd:YAG laser with optical coherence tomography for nonsurgical treatment of basal cell carcinoma. [2022]

3. Poland pubmed.ncbi.nlm.nih.gov

[Use of Nd:YAG laser for treatment of basal-cell carcinomas and some premalignant conditions]. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

An expanded study of long-pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Laser therapy of skin tumors. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Continuous-wave Nd:Yag laser hyperthermia: a successful modality in treatment of basal cell carcinoma. [2007]