Trial Outcomes & Findings for Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis (NCT NCT00116649)

Last Updated: 2010-07-20

Results Overview

Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

551 participants

Primary outcome timeframe

from first dose up to 18 months

Results posted on

2010-07-20

Participant Flow

Study start - 14 July 2005 at 31 study centers 500 subjects were planned, with up to 15 subjects enrolled at each study center; however, some study centers were unable to enroll 15 subjects, so active centers were asked to enroll additional subjects.

Open-label study - subjects were required to be at least 18 years of age and to have greater than 25 centimeters squared total treatment area(s) containing at least 4 clinically typical, visible, discrete, nonhypertrophic Actinic Keratosis lesions without any dermatological disease and/or condition in the treatment or surrounding area.

Participant milestones

Participant milestones
Measure	Aldara (Imiquimod) Cream Aldara (imiquimod) Cream 5%
Overall Study STARTED	551
Overall Study COMPLETED	396
Overall Study NOT COMPLETED	155

Reasons for withdrawal

Reasons for withdrawal
Measure	Aldara (Imiquimod) Cream Aldara (imiquimod) Cream 5%
Overall Study Adverse Event	20
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	32
Overall Study Withdrawal by Subject	68
Overall Study Local Skin Reaction	9
Overall Study Various Reasons	18
Overall Study Protocol Specified	7

Baseline Characteristics

Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aldara (Imiquimod) Cream n=551 Participants Aldara (imiquimod) Cream 5%
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	207 Participants n=5 Participants
Age, Categorical >=65 years	344 Participants n=5 Participants
Age Continuous	67.5 years STANDARD_DEVIATION 10.71 • n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants
Sex: Female, Male Male	437 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	529 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	551 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	551 participants n=5 Participants
Baseline actinic keratosis lesion count	45.5 actinic keratosis lesions STANDARD_DEVIATION 2.36 • n=5 Participants

PRIMARY outcome

Timeframe: from first dose up to 18 months

Population: There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Aldara (Imiquimod) Cream n=551 Participants Aldara (imiquimod) Cream 5%
Number of Participants Who Experienced an Adverse Event	472 participants

SECONDARY outcome

Timeframe: At Month 18

Population: The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit

Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count

Outcome measures

Outcome measures
Measure	Aldara (Imiquimod) Cream n=526 Participants Aldara (imiquimod) Cream 5%
Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count	80.2 percent reduction Standard Deviation 1.55

Adverse Events

Aldara (Imiquimod) Cream

Serious events: 39 serious events

Other events: 472 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aldara (Imiquimod) Cream n=551 participants at risk Aldara (imiquimod) Cream 5%
Cardiac disorders Bradycardia	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Cardiac disorders Myocardial infarction	0.73% 4/551 • Number of events 4 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Cardiac disorders Acute Myocardial Infarction	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Cardiac disorders Coronary artery disease	0.73% 4/551 • Number of events 4 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Infections and infestations Bacteraemia	0.18% 1/551 • Number of events 3 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Cardiac disorders Cardiac disorder	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Infections and infestations Urinary tract infection	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Vascular disorders Arteriosclerosis	0.36% 2/551 • Number of events 3 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Cardiac disorders Ventricular tachycardia	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Injury, poisoning and procedural complications Device failure	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Hepatobiliary disorders Hepatic cirrhosis	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Nervous system disorders Cerebrovascular accident	0.36% 2/551 • Number of events 2 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Musculoskeletal and connective tissue disorders Intrervertebral disc protrusion	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Infections and infestations Lobar pneumonia	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Nervous system disorders Syncope	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Injury, poisoning and procedural complications Concussion	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
General disorders Chest pain	0.36% 2/551 • Number of events 2 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Infections and infestations Pneumonia	0.36% 2/551 • Number of events 2 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Nervous system disorders Haemorrhagic stroke	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Infections and infestations Cellulitis	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Nervous system disorders Carotid artery occlusion	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Infections and infestations Upper respiratory tract infection	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Metabolism and nutrition disorders Dehydration	0.36% 2/551 • Number of events 2 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Musculoskeletal and connective tissue disorders Intervertebral disk protrusion	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Hepatobiliary disorders Cholelithiasis	0.36% 2/551 • Number of events 2 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Cardiac disorders Mitral valve incompetence	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Cardiac disorders Angina unstable	0.36% 2/551 • Number of events 2 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Hepatobiliary disorders Gallbladder disorder	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Vascular disorders Hypertension	0.18% 1/551 • Number of events 1 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.36% 2/551 • Number of events 2 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.

Other adverse events

Other adverse events
Measure	Aldara (Imiquimod) Cream n=551 participants at risk Aldara (imiquimod) Cream 5%
Skin and subcutaneous tissue disorders Actinic Keratosis	30.5% 168/551 • Number of events 168 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Skin and subcutaneous tissue disorders Application site pruritus	23.0% 127/551 • Number of events 127 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	15.1% 83/551 • Number of events 83 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	14.9% 82/551 • Number of events 82 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Skin and subcutaneous tissue disorders Skin lesion	10.7% 59/551 • Number of events 59 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
General disorders Application site irritation	8.7% 48/551 • Number of events 48 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Skin and subcutaneous tissue disorders Seborrhoeic Keratosis	7.6% 42/551 • Number of events 42 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
General disorders Fatigue	6.2% 34/551 • Number of events 34 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Skin and subcutaneous tissue disorders Skin Papilloma	6.0% 33/551 • Number of events 33 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
General disorders Application site pain	5.4% 30/551 • Number of events 30 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Infections and infestations Upper respiratory tract infection	4.9% 27/551 • Number of events 27 • Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence. Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.

Additional Information

Sharon Levy, MD VP Product Development

Graceway Pharmaceuticals LLC

Phone: 267-948-0500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place