Trial Outcomes & Findings for Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts (NCT NCT00735462)
NCT ID: NCT00735462
Last Updated: 2011-07-20
Results Overview
The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
511 participants
Primary outcome timeframe
Up to 16 weeks
Results posted on
2011-07-20
Participant Flow
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
|
202
|
204
|
105
|
|
Overall Study
COMPLETED
|
139
|
149
|
77
|
|
Overall Study
NOT COMPLETED
|
63
|
55
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Baseline characteristics by cohort
| Measure |
2.5% Imiquimod Cream
n=202 Participants
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
3.75% Imiquimod Cream
n=204 Participants
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
Placebo
n=105 Participants
Placebo cream applied once daily to wart areas for up to 8 weeks.
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
201 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
506 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age Continuous
|
33.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
222 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
202 participants
n=5 Participants
|
204 participants
n=7 Participants
|
105 participants
n=5 Participants
|
511 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeksThe complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
Outcome measures
| Measure |
2.5% Imiquimod Cream
n=202 Participants
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
3.75% Imiquimod Cream
n=204 Participants
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
Placebo
n=105 Participants
Placebo cream applied once daily to wart areas for up to 8 weeks.
|
|---|---|---|---|
|
Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.
|
0.248 proportion of participants
Interval 0.19 to 0.313
|
0.294 proportion of participants
Interval 0.233 to 0.362
|
0.09 proportion of participants
Interval 0.04 to 0.156
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: Analysis population was based on safety population which defined as for all subjects randomized and received at lease one dose. There was one subject who randomized to the 2.5% group but received one treatment kit of 3.75% imiq cream, so this subject was assigned to 3.75% for the safety analysis.
Treatment related defined as "probably related" or "related" by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators. Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction.
Outcome measures
| Measure |
2.5% Imiquimod Cream
n=201 Participants
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
3.75% Imiquimod Cream
n=205 Participants
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
Placebo
n=105 Participants
Placebo cream applied once daily to wart areas for up to 8 weeks.
|
|---|---|---|---|
|
Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period
Subjects with and Adverse Reactions (ARs)
|
37 participants
|
40 participants
|
3 participants
|
|
Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period
Subjects with Any Local Skin Reactions (LSRs)
|
123 participants
|
148 participants
|
41 participants
|
|
Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period
Number of Subjects who Took a Rest Period
|
55 participants
|
67 participants
|
3 participants
|
Adverse Events
2.5% Imiquimod Cream
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
3.75% Imiquimod Cream
Serious events: 6 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.5% Imiquimod Cream
n=201 participants at risk
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
3.75% Imiquimod Cream
n=205 participants at risk
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
Placebo
n=105 participants at risk
Placebo cream applied once daily to wart areas for up to 8 weeks.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Malignant melanoma
|
0.00%
0/201 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.98%
2/205 • Number of events 2 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/201 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.49%
1/205 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
Psychiatric disorders
Suicidal ideation
|
0.50%
1/201 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/205 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/201 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.49%
1/205 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/201 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/205 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.95%
1/105 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
Reproductive system and breast disorders
Ovarian cystectomy
|
0.50%
1/201 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/205 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
Vascular disorders
Diverticulitis
|
0.00%
0/201 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.49%
1/205 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
Endocrine disorders
Diabetes mellitus inadequate control
|
0.00%
0/201 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.49%
1/205 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
Other adverse events
| Measure |
2.5% Imiquimod Cream
n=201 participants at risk
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
3.75% Imiquimod Cream
n=205 participants at risk
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
|
Placebo
n=105 participants at risk
Placebo cream applied once daily to wart areas for up to 8 weeks.
|
|---|---|---|---|
|
General disorders
Application site pain
|
4.0%
8/201 • Number of events 8 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
7.8%
16/205 • Number of events 16 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
General disorders
Application site pruritus
|
7.0%
14/201 • Number of events 14 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
3.4%
7/205 • Number of events 7 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.95%
1/105 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
General disorders
Application site irritation
|
4.0%
8/201 • Number of events 8 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
5.4%
11/205 • Number of events 11 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.95%
1/105 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
General disorders
Application site rash
|
1.5%
3/201 • Number of events 3 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.98%
2/205 • Number of events 2 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
General disorders
Application site ulcer
|
1.5%
3/201 • Number of events 3 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.98%
2/205 • Number of events 2 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.00%
0/105 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
|
General disorders
Application site bleeding
|
0.50%
1/201 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.98%
2/205 • Number of events 2 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.
|
0.95%
1/105 • Number of events 1 • One year
The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 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 a term restricts that PI can publish their trial results within 12 months of completion of the trial.
- Publication restrictions are in place
Restriction type: OTHER