- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02251652
Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses
March 15, 2017 updated by: Gary Goldenberg, Icahn School of Medicine at Mount Sinai
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
16
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 11370
- Icahn School of Medicine at Mount Sinai
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Combination Therapy
Cryotherapy followed by Ingenol Mebutate Gel
|
Ingenol mebutate 0.05% gel
Other Names:
1-2 sprays, 5 seconds each, with a 5 second interval
|
Active Comparator: Cryotherapy Alone
Cryotherapy only
|
1-2 sprays, 5 seconds each, with a 5 second interval
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 57
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and Day 57
|
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
|
Baseline and Day 57
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 17, 2014
First Submitted That Met QC Criteria
September 25, 2014
First Posted (Estimate)
September 29, 2014
Study Record Updates
Last Update Posted (Actual)
April 26, 2017
Last Update Submitted That Met QC Criteria
March 15, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 13-0142
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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