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OpenTrials
Completed

NCT Number: NCT04936932

Laser Treatment of Basal Cell Carcinoma

Laser treatment of Basal cell carcinoma

Completed

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skin & Allergy Center

Spring Hill, Tennessee, 37174, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Pregnancy
  • Subjects unable to follow-up for the full 12-months
  • Subjects not willing to have biopsy taken from the treatment area
  • 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

Treatment and study plan

1064 nm long-pulse Nd:YAG laser

Device

BCC lesion will be treated with long-pulse 1064 laser

Primary outcomes

  1. Complete clearance of BCC

    Time frame: 1 year

    Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance

Secondary outcomes

  1. Cosmetic outcome

    Time frame: 1 year

    Cosmetic outcome and any adverse effects of the laser treatment will be assessed

Sponsors and collaborators

Lead sponsor

Sciton

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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