Trial Outcomes & Findings for Bioequivalence Study of Two Imiquimod Cream 5% (NCT NCT00828568)
NCT ID: NCT00828568
Last Updated: 2014-01-28
Results Overview
Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
425 participants
Primary outcome timeframe
24 weeks
Results posted on
2014-01-28
Participant Flow
Patients were recruited at 20 dermatology clinical practices.
Participant milestones
| Measure |
Imiquimod 5% Taro
Imiquimod 5% manufactured by Taro applied for 16 weeks
|
Aldara - Imiquimod 5%
Aldara, Imiquimod 5% applied for 16 weeks
|
Vehicle
Patients receiving imiquimod Vehicle for 16 weeks
|
|---|---|---|---|
|
Randomized
STARTED
|
184
|
179
|
62
|
|
Randomized
COMPLETED
|
183
|
179
|
60
|
|
Randomized
NOT COMPLETED
|
1
|
0
|
2
|
|
Treated - Received at Least One Dose
STARTED
|
183
|
179
|
60
|
|
Treated - Received at Least One Dose
COMPLETED
|
153
|
150
|
55
|
|
Treated - Received at Least One Dose
NOT COMPLETED
|
30
|
29
|
5
|
Reasons for withdrawal
| Measure |
Imiquimod 5% Taro
Imiquimod 5% manufactured by Taro applied for 16 weeks
|
Aldara - Imiquimod 5%
Aldara, Imiquimod 5% applied for 16 weeks
|
Vehicle
Patients receiving imiquimod Vehicle for 16 weeks
|
|---|---|---|---|
|
Randomized
Withdrawal by Subject
|
1
|
0
|
2
|
|
Treated - Received at Least One Dose
Adverse Event
|
11
|
8
|
1
|
|
Treated - Received at Least One Dose
Withdrawal by Subject
|
9
|
11
|
0
|
|
Treated - Received at Least One Dose
Lost to Follow-up
|
1
|
5
|
1
|
|
Treated - Received at Least One Dose
Protocol Violation
|
9
|
5
|
3
|
Baseline Characteristics
Bioequivalence Study of Two Imiquimod Cream 5%
Baseline characteristics by cohort
| Measure |
Imiquimod 5% Taro
n=183 Participants
Imiquimod 5% manufactured by Taro applied for 16 weeks
|
Aldara - Imiquimod 5%
n=179 Participants
Aldara, Imiquimod 5% applied for 16 weeks
|
Vehicle
n=60 Participants
Patients receiving imiquimod Vehicle for 16 weeks
|
Total
n=422 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
112 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
347 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
183 participants
n=5 Participants
|
179 participants
n=7 Participants
|
60 participants
n=5 Participants
|
422 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Per Protocol (PP) population
Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Outcome measures
| Measure |
Imiquimod 5% Taro
n=146 Participants
Imiquimod 5% manufactured by Taro applied for 16 weeks
|
Aldara - Imiquimod 5%
n=141 Participants
Aldara, Imiquimod 5% applied for 16 weeks
|
Vehicle
Patients receiving imiquimod vehicle for 16 weeks
|
|---|---|---|---|
|
Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%
|
63 Participants
|
54 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intention to Treat (ITT) Population
Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Outcome measures
| Measure |
Imiquimod 5% Taro
n=180 Participants
Imiquimod 5% manufactured by Taro applied for 16 weeks
|
Aldara - Imiquimod 5%
n=176 Participants
Aldara, Imiquimod 5% applied for 16 weeks
|
Vehicle
n=60 Participants
Patients receiving imiquimod vehicle for 16 weeks
|
|---|---|---|---|
|
Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline
|
74 Participants
|
64 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Safety group includes all patients who received a single dose
For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.
Outcome measures
| Measure |
Imiquimod 5% Taro
n=183 Participants
Imiquimod 5% manufactured by Taro applied for 16 weeks
|
Aldara - Imiquimod 5%
n=179 Participants
Aldara, Imiquimod 5% applied for 16 weeks
|
Vehicle
n=60 Participants
Patients receiving imiquimod vehicle for 16 weeks
|
|---|---|---|---|
|
Patients Reporting at Least One Adverse Event
|
69 Participants
|
57 Participants
|
15 Participants
|
Adverse Events
Imiquimod 5% Taro
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Aldara - Imiquimod 5%
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imiquimod 5% Taro
n=183 participants at risk
Imiquimod 5% manufactured by Taro applied for 16 weeks
|
Aldara - Imiquimod 5%
n=179 participants at risk
Aldara, Imiquimod 5% applied for 16 weeks
|
Vehicle
n=60 participants at risk
Patients receiving imiquimod Vehicle for 16 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/183 • Assessed at 24 weeks
|
0.56%
1/179 • Number of events 1 • Assessed at 24 weeks
|
1.7%
1/60 • Number of events 1 • Assessed at 24 weeks
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/183 • Assessed at 24 weeks
|
0.56%
1/179 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.55%
1/183 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/179 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/183 • Assessed at 24 weeks
|
0.56%
1/179 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/183 • Assessed at 24 weeks
|
0.56%
1/179 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/183 • Assessed at 24 weeks
|
0.56%
1/179 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/183 • Assessed at 24 weeks
|
0.56%
1/179 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.55%
1/183 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/179 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.55%
1/183 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/179 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Nervous system disorders
SYNCOPE
|
0.55%
1/183 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/179 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/183 • Assessed at 24 weeks
|
0.56%
1/179 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.55%
1/183 • Number of events 1 • Assessed at 24 weeks
|
0.00%
0/179 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
Other adverse events
| Measure |
Imiquimod 5% Taro
n=183 participants at risk
Imiquimod 5% manufactured by Taro applied for 16 weeks
|
Aldara - Imiquimod 5%
n=179 participants at risk
Aldara, Imiquimod 5% applied for 16 weeks
|
Vehicle
n=60 participants at risk
Patients receiving imiquimod Vehicle for 16 weeks
|
|---|---|---|---|
|
General disorders
APPLICATION SITE ERYTHEMA
|
6.0%
11/183 • Number of events 12 • Assessed at 24 weeks
|
4.5%
8/179 • Number of events 8 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
General disorders
APPLICATION SITE IRRITATION
|
2.7%
5/183 • Number of events 5 • Assessed at 24 weeks
|
5.0%
9/179 • Number of events 9 • Assessed at 24 weeks
|
0.00%
0/60 • Assessed at 24 weeks
|
|
General disorders
APPLICATION SITE PRURITUS
|
4.9%
9/183 • Number of events 9 • Assessed at 24 weeks
|
5.0%
9/179 • Number of events 9 • Assessed at 24 weeks
|
1.7%
1/60 • Number of events 1 • Assessed at 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.55%
1/183 • Number of events 1 • Assessed at 24 weeks
|
0.56%
1/179 • Number of events 1 • Assessed at 24 weeks
|
5.0%
3/60 • Number of events 5 • Assessed at 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60