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

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

Participant Flow

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
Arm/Group Description	Each subject is its own control - l...
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

Baseline Characteristics

Arm/Group Title		Actinic Keratosis
Arm/Group Description		Each subject is its own control - l...
Arm/Group Description		Each subject is its own control - left dorsal hand compared to right dorsal hand
Overall Number of Baseline Participants		16
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1.Primary Outcome


Title	Safety of Combination Therapy vs Cryotherapy Alone
Description	To evaluate the safety of cryotherapy plus ingenol mebutate on dorsal ...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Combination Therapy	Cryotherapy Alone
Arm/Group Description:	Cryotherapy followed by Ingenol Meb...	Cryotherapy only ...
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
Description	To evaluate and compare the mean reduction in number of all AKs (hyper...
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

Outcome Measure Data

Analysis Population Description

Comparisons of proportion of responders between treated and control hands


Arm/Group Title	Combination Therapy	Cryotherapy Alone
Arm/Group Description:	Cryotherapy followed by Ingenol Meb...	Cryotherapy only ...
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
Description	To evaluate the number of AKs (both hypertrophic and non-hypertrophic)...
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

Outcome Measure Data

Analysis Population Description

Comparisons of proportion of responders between treated and control hands


Arm/Group Title	Combination Therapy	Cryotherapy Alone
Arm/Group Description:	Cryotherapy followed by Ingenol Meb...	Cryotherapy only ...
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Combination Therapy	Cryotherapy Alone
Arm/Group Description	Cryotherapy followed by Ingenol Meb...	Cryotherapy only ...
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%)
Serious Adverse Events Serious Adverse Events
	Combination Therapy	Cryotherapy Alone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/16 (0.00%)	0/16 (0.00%)
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%)

Limitations and Caveats

Study limitations include small sample size and the fact that LSRs may unblind the investigator.

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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