Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Actinic Keratoses
Interventions Drug: Ingenol Mebutate
Procedure: Cryotherapy
Enrollment 16
Recruitment Details Subjects were recruited from the Faculty Practice and resident clinics at Mount Sinai. Seventeen subjects were enrolled in the study; one subject withdrew consent prior to treatment.
Pre-assignment Details  
Arm/Group Title Actinic Keratosis
Hide Arm/Group Description Each subject is its own control - left dorsal hand compared to right dorsal hand
Period Title: Overall Study
Started 17
Completed 16
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Actinic Keratosis
Hide Arm/Group Description Each subject is its own control - left dorsal hand compared to right dorsal hand
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
67.06  (9.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
1
   6.3%
Male
15
  93.8%
1.Primary Outcome
Title Safety of Combination Therapy vs Cryotherapy Alone
Hide Description 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.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Therapy Cryotherapy Alone
Hide Arm/Group Description:

Cryotherapy followed by Ingenol Mebutate Gel

Ingenol Mebutate: Ingenol mebutate 0.05% gel

Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval

Cryotherapy only

Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval

Overall Number of Participants Analyzed 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Change in Number of All Actinic Keratoses
Hide Description 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
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Comparisons of proportion of responders between treated and control hands
Arm/Group Title Combination Therapy Cryotherapy Alone
Hide Arm/Group Description:

Cryotherapy followed by Ingenol Mebutate Gel

Ingenol Mebutate: Ingenol mebutate 0.05% gel

Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval

Cryotherapy only

Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval

Overall Number of Participants Analyzed 16 16
Overall Number of Units Analyzed
Type of Units Analyzed: Actinic Keratoses lesions
73 87
Mean (Standard Deviation)
Unit of Measure: percent change
-4.6  (2.66) -2.5  (1.37)
3.Secondary Outcome
Title Change in Actinic Keratoses by Anatomic Site
Hide Description 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
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Comparisons of proportion of responders between treated and control hands
Arm/Group Title Combination Therapy Cryotherapy Alone
Hide Arm/Group Description:

Cryotherapy followed by Ingenol Mebutate Gel

Ingenol Mebutate: Ingenol mebutate 0.05% gel

Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval

Cryotherapy only

Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval

Overall Number of Participants Analyzed 16 16
Overall Number of Units Analyzed
Type of Units Analyzed: Actinic Keratoses lesions
73 87
Mean (Standard Deviation)
Unit of Measure: percent change
Hypertrophic -86.34  (16.642) -51.89  (19.091)
Non-hypertrophic -4.1  (3.38) 0.0  (0.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combination Therapy Cryotherapy Alone
Hide Arm/Group Description

Cryotherapy followed by Ingenol Mebutate Gel

Ingenol Mebutate: Ingenol mebutate 0.05% gel

Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval

Cryotherapy only

Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval

All-Cause Mortality
Combination Therapy Cryotherapy Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
Combination Therapy Cryotherapy Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Combination Therapy Cryotherapy Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Study limitations include small sample size and the fact that LSRs may unblind the investigator.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gary Goldenberg
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-9728
EMail: garygoldenbergmd@gmail.com
Layout table for additonal information
Responsible Party: Gary Goldenberg, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02251652    
Other Study ID Numbers: GCO 13-0142
First Submitted: September 17, 2014
First Posted: September 29, 2014
Results First Submitted: March 15, 2017
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017