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New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

Primary Purpose

Basal Cell Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cynosure Cynergy Nd:YAG Laser 1064nm
Sponsored by
Dr. Stephanie Geisler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with one or more basal cell carcinoma(s) on head, trunk or extremities

  • Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography
  • H zone <6mm, M zone <10mm, L zone <20mm
  • Tumor thickness <2mm
  • Clearly visible margins

Exclusion Criteria:

  • Pregnancy
  • <18 years of age
  • Current or history of immunosuppression
  • Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas
  • History of radiation in the area of basal cell carcinoma appearance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Nd:YAG treatment arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas
    Clearance rate of basal cell carcinomas after 1-3 Nd:YAG laser treatments evaluated by clinical inspectation, dermatosopy and optical coherence tomography.
    Recurrence Rate after Nd:YAG Laser treatment
    To assess the recurrence rate after a long-term follow-up of 6 and 12 months

    Secondary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
    To assess treatment tolerability of the Nd:YAG Laser 1064-nm (e.g. pain according to a Numerical rating scale, scarring, wound healing, secondary infection rate)
    Cosmetic outcome after laser treatment
    This will be assess according to an assessment scale including following parameters: Pigmentation: hyperpigmentation, hypopigmentation, normal Vascularity: pink, red, purple, normal Pliability: firm, contracture, supple, yielding, ropes, normal Scarring: yes, no Overall opinion: Rating on a scale from 1-5 (school note system) Separate evaluation of observer and patient.

    Full Information

    First Posted
    October 5, 2021
    Last Updated
    April 5, 2022
    Sponsor
    Dr. Stephanie Geisler
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05324202
    Brief Title
    New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management
    Official Title
    New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    April 2023 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr. Stephanie Geisler

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Basal Cell Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nd:YAG treatment arm
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Cynosure Cynergy Nd:YAG Laser 1064nm
    Intervention Description
    The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).
    Primary Outcome Measure Information:
    Title
    Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas
    Description
    Clearance rate of basal cell carcinomas after 1-3 Nd:YAG laser treatments evaluated by clinical inspectation, dermatosopy and optical coherence tomography.
    Time Frame
    8 weeks after the treatment
    Title
    Recurrence Rate after Nd:YAG Laser treatment
    Description
    To assess the recurrence rate after a long-term follow-up of 6 and 12 months
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
    Description
    To assess treatment tolerability of the Nd:YAG Laser 1064-nm (e.g. pain according to a Numerical rating scale, scarring, wound healing, secondary infection rate)
    Time Frame
    6 and 12 months after treatment
    Title
    Cosmetic outcome after laser treatment
    Description
    This will be assess according to an assessment scale including following parameters: Pigmentation: hyperpigmentation, hypopigmentation, normal Vascularity: pink, red, purple, normal Pliability: firm, contracture, supple, yielding, ropes, normal Scarring: yes, no Overall opinion: Rating on a scale from 1-5 (school note system) Separate evaluation of observer and patient.
    Time Frame
    6 and 12 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with one or more basal cell carcinoma(s) on head, trunk or extremities Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography H zone <6mm, M zone <10mm, L zone <20mm Tumor thickness <2mm Clearly visible margins Exclusion Criteria: Pregnancy <18 years of age Current or history of immunosuppression Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas History of radiation in the area of basal cell carcinoma appearance

    12. IPD Sharing Statement

    Learn more about this trial

    New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

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