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Electrocautery vs Q-switch for Seborrheic Keratosis

Primary Purpose

Keratosis, Seborrheic

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyfrecator
532 nm Q-switched Nd:YAG laser
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratosis, Seborrheic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects are Caucasian or Asian.
  2. Subjects who are between 18-65 year olds.
  3. Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy.
  4. Subjects have Fitzpatrick skin type I-III.
  5. Subjects are in good health.
  6. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion Criteria:

  1. History of keloids or hypertrophic scars.
  2. Pregnant or lactating or intends to become pregnant in the next 3 months.
  3. Active skin disease or skin infection in the treatment area.
  4. Previous history of lidocaine allergy.
  5. History of methemoglobinemia
  6. Unable to understand the protocol or to give informed consent.
  7. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    electrocautery

    532 nm Nd:YAG laser

    Arm Description

    Blocks of subjects' lesions will be randomized 1:1 to receive electrocautery or 532 nm Nd:YAG laser. Prior to treatment with either electrocautery or 532nm Q-switched Nd:YAG laser, a topical EMLA cream will be applied to the lesions for at least 60 minutes under occlusion at the area of treatment.

    Blocks of subjects' lesions will be randomized 1:1 to receive electrocautery or 532 nm Nd:YAG laser. Prior to treatment with either electrocautery or 532nm Q-switched Nd:YAG laser, a topical EMLA cream will be applied to the lesions for at least 60 minutes under occlusion at the area of treatment.

    Outcomes

    Primary Outcome Measures

    Change in Pigmentation from baseline to week 18
    Blinded photo raters will the lesion pigmentation on a scale of -50 (most hypopigmented relative to baseline) to +50 (most hyperpigmented relative to baseline) for both treatments.
    Change in lesion texture from baseline to week 18
    Blinded photo raters will the lesion texture on a scale of -50 (most worsening relative to baseline) to +50 (most improvement relative to baseline) for both treatments.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 12, 2015
    Last Updated
    December 2, 2021
    Sponsor
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02366559
    Brief Title
    Electrocautery vs Q-switch for Seborrheic Keratosis
    Official Title
    Comparing the Efficacy and Risk of Adverse Events of Electrocautery Versus 532 nm Qswitched Neodymium-doped Yttrium Aluminium Garnet Laser for the Treatment of Flat Seborrheic Keratoses: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary objective of this study is to compare the efficacy and risk of adverse events of electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of flat seborrheic keratoses. This study is a pilot study designed to determine feasibility of these procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratosis, Seborrheic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    electrocautery
    Arm Type
    Active Comparator
    Arm Description
    Blocks of subjects' lesions will be randomized 1:1 to receive electrocautery or 532 nm Nd:YAG laser. Prior to treatment with either electrocautery or 532nm Q-switched Nd:YAG laser, a topical EMLA cream will be applied to the lesions for at least 60 minutes under occlusion at the area of treatment.
    Arm Title
    532 nm Nd:YAG laser
    Arm Type
    Active Comparator
    Arm Description
    Blocks of subjects' lesions will be randomized 1:1 to receive electrocautery or 532 nm Nd:YAG laser. Prior to treatment with either electrocautery or 532nm Q-switched Nd:YAG laser, a topical EMLA cream will be applied to the lesions for at least 60 minutes under occlusion at the area of treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Hyfrecator
    Intervention Type
    Device
    Intervention Name(s)
    532 nm Q-switched Nd:YAG laser
    Primary Outcome Measure Information:
    Title
    Change in Pigmentation from baseline to week 18
    Description
    Blinded photo raters will the lesion pigmentation on a scale of -50 (most hypopigmented relative to baseline) to +50 (most hyperpigmented relative to baseline) for both treatments.
    Time Frame
    Baseline and 18 weeks
    Title
    Change in lesion texture from baseline to week 18
    Description
    Blinded photo raters will the lesion texture on a scale of -50 (most worsening relative to baseline) to +50 (most improvement relative to baseline) for both treatments.
    Time Frame
    Baseline and 18 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects are Caucasian or Asian. Subjects who are between 18-65 year olds. Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy. Subjects have Fitzpatrick skin type I-III. Subjects are in good health. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator. Exclusion Criteria: History of keloids or hypertrophic scars. Pregnant or lactating or intends to become pregnant in the next 3 months. Active skin disease or skin infection in the treatment area. Previous history of lidocaine allergy. History of methemoglobinemia Unable to understand the protocol or to give informed consent. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Murad Alam, MD
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Electrocautery vs Q-switch for Seborrheic Keratosis

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