Trial Outcomes & Findings for Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts (NCT NCT00674739)
NCT ID: NCT00674739
Last Updated: 2011-05-24
Results Overview
Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
470 participants
Primary outcome timeframe
Up to 16 weeks
Results posted on
2011-05-24
Participant Flow
Recruitment period from June to December 2008 from 30 clinical study centers in the USA
Participant milestones
| Measure |
2.5% Imiquimod Cream
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
3.75% Imiquimod Cream
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
Placebo
Placebo cream applied once daily to wart areas for up to 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
178
|
195
|
97
|
|
Overall Study
COMPLETED
|
121
|
136
|
65
|
|
Overall Study
NOT COMPLETED
|
57
|
59
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Baseline characteristics by cohort
| Measure |
2.5% Imiquimod Cream
n=178 Participants
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
3.75% Imiquimod Cream
n=195 Participants
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
Placebo
n=97 Participants
Placebo cream applied once daily to wart areas for up to 8 weeks
|
Total
n=470 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
173 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
453 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age Continuous
|
32.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
30.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
178 participants
n=5 Participants
|
195 participants
n=7 Participants
|
97 participants
n=5 Participants
|
470 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeksPopulation: Intention to treat
Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.
Outcome measures
| Measure |
2.5% Imiquimod Cream
n=178 Participants
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
3.75% Imiquimod Cream
n=195 Participants
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
Placebo
n=97 Participants
Placebo cream applied once daily to wart areas for up to 8 weeks
|
|---|---|---|---|
|
Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
|
0.191 participants
Interval 0.136 to 0.257
|
0.272 participants
Interval 0.211 to 0.34
|
0.103 participants
Interval 0.051 to 0.181
|
SECONDARY outcome
Timeframe: Up to 16 weeksLocal skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit. Rest period was a temporary interruption of dosing dur to intolerable LSRs.
Outcome measures
| Measure |
2.5% Imiquimod Cream
n=178 Participants
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
3.75% Imiquimod Cream
n=195 Participants
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
Placebo
n=97 Participants
Placebo cream applied once daily to wart areas for up to 8 weeks
|
|---|---|---|---|
|
Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
Adverse Reactions
|
27 participants
|
30 participants
|
2 participants
|
|
Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
Local Skin Reactions
|
110 participants
|
144 participants
|
29 participants
|
|
Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
Number of Subjects with Rest Period in Treatment
|
49 participants
|
59 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: Patients with adverse events considered probably related or related to the administration of the product.
Numbers of subjects in each treatment group reporting one or more adverse events
Outcome measures
| Measure |
2.5% Imiquimod Cream
n=178 Participants
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
3.75% Imiquimod Cream
n=195 Participants
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
Placebo
n=97 Participants
Placebo cream applied once daily to wart areas for up to 8 weeks
|
|---|---|---|---|
|
Treatment Related Adverse Events
|
27 Participants
|
30 Participants
|
2 Participants
|
Adverse Events
2.5% Imiquimod Cream
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
3.75% Imiquimod Cream
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.5% Imiquimod Cream
n=178 participants at risk
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
3.75% Imiquimod Cream
n=195 participants at risk
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
Placebo
n=197 participants at risk；n=97 participants at risk
Placebo cream applied once daily to wart areas for up to 8 weeks
|
|---|---|---|---|
|
General disorders
Pelvic Mass
|
0.00%
0/178 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.51%
1/195 • Number of events 1 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/97 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/178 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.51%
1/195 • Number of events 1 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/97 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/178 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.51%
1/195 • Number of events 1 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/97 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.56%
1/178 • Number of events 1 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/195 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/97 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
|
Nervous system disorders
Migraine
|
0.56%
1/178 • Number of events 1 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/195 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/97 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
|
Nervous system disorders
Syncope
|
0.56%
1/178 • Number of events 1 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/195 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
0.00%
0/97 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
Other adverse events
| Measure |
2.5% Imiquimod Cream
n=178 participants at risk
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
3.75% Imiquimod Cream
n=195 participants at risk
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
|
Placebo
n=197 participants at risk；n=97 participants at risk
Placebo cream applied once daily to wart areas for up to 8 weeks
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Application site pain
|
6.7%
12/178 • Number of events 12 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
5.6%
11/195 • Number of events 11 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
1.0%
1/97 • Number of events 1 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
|
Skin and subcutaneous tissue disorders
Application site irritation
|
2.8%
5/178 • Number of events 5 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
6.2%
12/195 • Number of events 12 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
1.0%
1/97 • Number of events 1 • One year
The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months
|
Additional Information
Robert Babilon, Vice President, Product Development
Graceway Pharmaceuticals
Phone: 267-948-0400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee For few PIs, there were a restrict that the PI can not publish their trial results with 12 months from the completion of the trial.
- Publication restrictions are in place
Restriction type: OTHER