search
Back to results

Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

Primary Purpose

Actinic Keratosis

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ingenol mebutate
cryotherapy
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female subjects between 18 and 89 years old.
  • Have at least a total of 10 non-hypertrophic actinic keratoses (AKs) on the face and scalp
  • The subjects are in good health
  • The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and are able to communicate with the investigator

Exclusion Criteria:

  • Subjects under 18 years of age and over the age of 89
  • Subjects who are pregnant or lactating
  • Subjects with sensitivity to cold
  • Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
  • Subjects who received previous treatment of target AKs
  • Subjects whose target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma
  • Subjects with use of medications or other treatments that could interfere with evaluation of the treatment area within 2 months before study entry (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
  • Subjects who are unable to understand the protocol or to give informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ingenol Mebutate

    Cryotherapy

    Arm Description

    Ingenol Mebutate applied to one side of face with skin lesions

    Cryotherapy applied to other side of face with skin lesions

    Outcomes

    Primary Outcome Measures

    Change from baseline in visual assessment scores at 3 months
    The visual assessment evaluates seven clinical signs: erythema, edema, wheal vesiculation, ulceration, hemorrhage, purpura, and crusting. Each sign is assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a better outcome, and a score of 3 is associated with severe expression of the clinical sign and a worse outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 5, 2012
    Last Updated
    December 2, 2021
    Sponsor
    Northwestern University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01735942
    Brief Title
    Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions
    Official Title
    A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    May 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 purpose of this study is to find out the effectiveness of ingenol mebutate compared to cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ingenol Mebutate
    Arm Type
    Experimental
    Arm Description
    Ingenol Mebutate applied to one side of face with skin lesions
    Arm Title
    Cryotherapy
    Arm Type
    Active Comparator
    Arm Description
    Cryotherapy applied to other side of face with skin lesions
    Intervention Type
    Drug
    Intervention Name(s)
    Ingenol mebutate
    Intervention Type
    Procedure
    Intervention Name(s)
    cryotherapy
    Primary Outcome Measure Information:
    Title
    Change from baseline in visual assessment scores at 3 months
    Description
    The visual assessment evaluates seven clinical signs: erythema, edema, wheal vesiculation, ulceration, hemorrhage, purpura, and crusting. Each sign is assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a better outcome, and a score of 3 is associated with severe expression of the clinical sign and a worse outcome.
    Time Frame
    Baseline and 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male and female subjects between 18 and 89 years old. Have at least a total of 10 non-hypertrophic actinic keratoses (AKs) on the face and scalp The subjects are in good health The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and are able to communicate with the investigator Exclusion Criteria: Subjects under 18 years of age and over the age of 89 Subjects who are pregnant or lactating Subjects with sensitivity to cold Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry Subjects who received previous treatment of target AKs Subjects whose target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma Subjects with use of medications or other treatments that could interfere with evaluation of the treatment area within 2 months before study entry (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids) Subjects who are unable to understand the protocol or to give informed consent
    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

    Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

    We'll reach out to this number within 24 hrs