Clinical Trials /

Laser Treatment of Basal Cell Carcinoma

NCT04936932

Description:

Laser treatment of Basal cell carcinoma

Related Conditions:
  • Superficial Basal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT04936932

Trial Eligibility

Document

Title

  • Brief Title: Laser Treatment of Basal Cell Carcinoma
  • Official Title: Laser Treatment of Basal Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: BCCCIP001
  • NCT ID: NCT04936932

Conditions

  • Basal Cell Carcinoma

Purpose

Laser treatment of Basal cell carcinoma

Detailed Description

      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.

Trial Arms

NameTypeDescriptionInterventions
StandardActive Comparator1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec
    SlowActive Comparator1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec

      Eligibility Criteria

              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
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:Accepts Healthy Volunteers

      Primary Outcome Measures

      Measure:Complete clearance of BCC
      Time Frame:1 year
      Safety Issue:
      Description:Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance

      Secondary Outcome Measures

      Measure:Cosmetic outcome
      Time Frame:1 year
      Safety Issue:
      Description:Cosmetic outcome and any adverse effects of the laser treatment will be assessed

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Sciton

      Trial Keywords

      • Superficial Basal Cell Carcinoma

      Last Updated

      June 25, 2021