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Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses

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ClinicalTrials.gov Identifier: NCT02251652
Recruitment Status : Completed
First Posted : September 29, 2014
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Gary Goldenberg, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE September 17, 2014
First Posted Date  ICMJE September 29, 2014
Results First Submitted Date  ICMJE March 15, 2017
Results First Posted Date  ICMJE April 26, 2017
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
Safety of Combination Therapy vs Cryotherapy Alone [ Time Frame: Day 57 ]
To evaluate the safety of cryotherapy plus ingenol mebutate on dorsal hands and compare it to the safety of cryotherapy alone looking at Adverse Events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
  • Change in Number of All Actinic Keratoses [ Time Frame: Baseline and Day 57 ]
    To evaluate and compare the mean reduction in number of all AKs (hypertrophic and non-hypertrophic) on the dorsal hands of the combination cryotherapy- ingenol mebutate treated side vs. the cryotherapy alone side on Day 57 as compared to baseline
  • Change in Actinic Keratoses by Anatomic Site [ Time Frame: Baseline and Day 57 ]
    To evaluate the number of AKs (both hypertrophic and non-hypertrophic) before therapy by anatomic site (dorsal hand) at Day 57 as compared to baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • Reduction in number of all Actinic Keratoses [ Time Frame: Baseline and Day 57 ]
    To evaluate and compare the mean reduction in number of all AKs (hypertrophic and non-hypertrophic) on the dorsal hands of the combination cryotherapy- ingenol mebutate treated side vs. the cryotherapy alone side on Day 57 as compared to baseline
  • Reduction in Actinic Keratoses by Anatomic Site [ Time Frame: Baseline and Day 57 ]
    To evaluate the number of AKs (both hypertrophic and non-hypertrophic) before therapy by anatomic site (dorsal hand) at Day 57 as compared to baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses
Official Title  ICMJE An Investigator-Initiated Study to Assess the Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses (AK) on Dorsal Hands
Brief Summary Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore, use of ingenol mebutate will also be evaluated for potential treatment of subclinical lesions.
Detailed Description The investigators plan to treat 30 subjects. Each qualifying subject will have at least 3 hypertrophic AKs, defined as more than 3mm in thickness, on each dorsal hand. Cryotherapy will be standardized in all patients and for all treated lesions: 1-2 sprays, 5 seconds each, with a 5 second interval. All subjects will be treated with the same cryo-spray. Following cryotherapy, subjects will be randomized to treat either their right or left dorsal hand with ingenol mebutate gel. The decision to treat the right vs. the left hand will be chosen by chance, like flipping a coin. Neither the subject nor the study doctor will choose what arm receives the ingenol mebutate gel. The study doctor will not know which arm is treated with ingenol mebutate, so the subject should not reveal that information to him or her at any time during the study. Subjects will treat the randomized dorsal hand with ingenol mebutate 0.05% gel starting on the same day as the cryotherapy (Day 0). Subjects will utilize the once daily for two days regimen. Subjects will be followed on day 4 after their initial visit, day 8, day 15, day 29, and day 57, with a two day window period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Actinic Keratoses
Intervention  ICMJE
  • Drug: Ingenol Mebutate
    Ingenol mebutate 0.05% gel
    Other Name: PEP005 Gel
  • Procedure: Cryotherapy
    1-2 sprays, 5 seconds each, with a 5 second interval
Study Arms  ICMJE
  • Active Comparator: Combination Therapy
    Cryotherapy followed by Ingenol Mebutate Gel
    Interventions:
    • Drug: Ingenol Mebutate
    • Procedure: Cryotherapy
  • Active Comparator: Cryotherapy Alone
    Cryotherapy only
    Intervention: Procedure: Cryotherapy
Publications * Hashim PW, Nia JK, Singer S, Goldenberg G. An Investigator-initiated Study to Assess the Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryosurgery in the Treatment of Hypertrophic Actinic Keratosis on Dorsal Hands. J Clin Aesthet Dermatol. 2016 Jul;9(7):16-22. Epub 2016 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2015)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2014)
30
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults at least 18 years old.
  • Subjects must be in good general health as confirmed by the medical history.
  • Subjects must be able to read, sign, and understand the informed consent
  • Prior to cryosurgery, subjects have at least 3 hypertrophic actinic keratoses on each dorsal hand.
  • Subject must be willing to forego any other treatments on the dorsum of the hands, including tanning bed use and excessive sun exposure while in the study.
  • Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
  • If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.

Exclusion Criteria:

  • Subjects with a history of melanoma anywhere on the body.
  • Subjects with an unstable medical condition as deemed by the clinical investigator.
  • Subjects with non-melanoma skin cancer on the dorsum of the hands.
  • Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
  • Subjects who have previously been treated with ingenol mebutate: on the dorsum of the hands in the past 6 months; or outside of the study area within the past 30 days.
  • Women who are pregnant, lactating, or planning to become pregnant during the study period.
  • Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
  • Subjects who have active chemical dependency or alcoholism as assessed by the investigator.
  • Subjects who have known allergies to any excipient in the study gel.
  • Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
  • Subjects who have received any of the following within 90 days prior to study treatment initiation:

    • interferon or interferon inducers
    • cytotoxic drugs
    • immunomodulators or immunosuppressive therapies (inhaled/ intranasal steroids are permitted)
    • oral or parenteral corticosteroids
    • topical corticosteroids if greater than 2 gm/day
    • any dermatologic procedures or surgeries on the study area (including any AK treatments)
  • Subjects who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02251652
Other Study ID Numbers  ICMJE GCO 13-0142
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Goldenberg, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE LEO Pharma
Investigators  ICMJE
Principal Investigator: Gary Goldenberg, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP