Trial Outcomes & Findings for Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses (NCT NCT02251652)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

Day 57

Results posted on

2017-04-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Actinic Keratosis Each subject is its own control - left dorsal hand compared to right dorsal hand
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Actinic Keratosis Each subject is its own control - left dorsal hand compared to right dorsal hand
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Actinic Keratosis n=16 Participants Each subject is its own control - left dorsal hand compared to right dorsal hand
Age, Continuous	67.06 years STANDARD_DEVIATION 9.82 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Combination Therapy n=16 Participants 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 Alone n=16 Participants Cryotherapy only Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval
Safety of Combination Therapy vs Cryotherapy Alone	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: Comparisons of proportion of responders between treated and control hands

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

Outcome measures

Outcome measures
Measure	Combination Therapy n=73 Actinic Keratoses lesions 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 Alone n=87 Actinic Keratoses lesions Cryotherapy only Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval
Change in Number of All Actinic Keratoses	-4.6 percent change Standard Deviation 2.66	-2.5 percent change Standard Deviation 1.37

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: Comparisons of proportion of responders between treated and control hands

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

Outcome measures

Outcome measures
Measure	Combination Therapy n=73 Actinic Keratoses lesions 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 Alone n=87 Actinic Keratoses lesions Cryotherapy only Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval
Change in Actinic Keratoses by Anatomic Site Hypertrophic	-86.34 percent change Standard Deviation 16.642	-51.89 percent change Standard Deviation 19.091
Change in Actinic Keratoses by Anatomic Site Non-hypertrophic	-4.1 percent change Standard Deviation 3.38	0.0 percent change Standard Deviation 0.0

Adverse Events

Combination Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cryotherapy Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gary Goldenberg

Icahn School of Medicine at Mount Sinai

Phone: 212-241-9728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place