Laser Treatment of Basal Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-08-20

Brief Summary

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Laser treatment of Basal cell carcinoma

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Detailed Description

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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.

Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard

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

Group Type ACTIVE_COMPARATOR

1064 nm long-pulse Nd:YAG laser

Intervention Type DEVICE

BCC lesion will be treated with long-pulse 1064 laser

Slow

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

Group Type ACTIVE_COMPARATOR

1064 nm long-pulse Nd:YAG laser

Intervention Type DEVICE

BCC lesion will be treated with long-pulse 1064 laser

Interventions

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1064 nm long-pulse Nd:YAG laser

BCC lesion will be treated with long-pulse 1064 laser

Intervention Type DEVICE

1064 nm long-pulse Nd:YAG laser

BCC lesion will be treated with long-pulse 1064 laser

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Healthy subjects 18 years of age or older
2. Lesion is biopsy-proven superficial BCC \<= 2.0 cm in largest diameter
3. BCC is on trunk or extremities
4. Seeks and is scheduled for treatment of BCC
5. Willing to have photographs taken of the treatment area
6. Ability to understand and the willingness to sign a written informed consent document
7. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria

1. 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.
2. Pregnancy
3. Subjects unable to follow-up for the full 12-months
4. Subjects not willing to have biopsy taken from the treatment area
5. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes