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Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts

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ClinicalTrials.gov Identifier: NCT00735462
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Genital Warts
Interventions Drug: 2.5% imiquimod cream
Drug: 3.75% imiquimod cream
Drug: Placebo cream
Enrollment 511
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2.5% Imiquimod Cream 3.75% Imiquimod Cream Placebo
Hide Arm/Group Description 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks. 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks. Placebo cream applied once daily to wart areas for up to 8 weeks.
Period Title: Overall Study
Started 202 204 105
Completed 139 149 77
Not Completed 63 55 28
Arm/Group Title 2.5% Imiquimod Cream 3.75% Imiquimod Cream Placebo Total
Hide Arm/Group Description 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks. 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks. Placebo cream applied once daily to wart areas for up to 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 202 204 105 511
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 204 participants 105 participants 511 participants
<=18 years
1
   0.5%
2
   1.0%
0
   0.0%
3
   0.6%
Between 18 and 65 years
201
  99.5%
201
  98.5%
104
  99.0%
506
  99.0%
>=65 years
0
   0.0%
1
   0.5%
1
   1.0%
2
   0.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 202 participants 204 participants 105 participants 511 participants
33.1  (10.1) 32.8  (11.0) 33.3  (10.8) 33.1  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 204 participants 105 participants 511 participants
Female
117
  57.9%
116
  56.9%
56
  53.3%
289
  56.6%
Male
85
  42.1%
88
  43.1%
49
  46.7%
222
  43.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 202 participants 204 participants 105 participants 511 participants
202 204 105 511
1.Primary Outcome
Title Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.
Hide Description The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
Time Frame Up to 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.5% Imiquimod Cream 3.75% Imiquimod Cream Placebo
Hide Arm/Group Description:
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
Placebo cream applied once daily to wart areas for up to 8 weeks.
Overall Number of Participants Analyzed 202 204 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.248
(0.190 to 0.313)
0.294
(0.233 to 0.362)
0.09
(0.040 to 0.156)
2.Secondary Outcome
Title 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
Hide Description

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.

Time Frame Up to 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 2.5% Imiquimod Cream 3.75% Imiquimod Cream Placebo
Hide Arm/Group Description:
2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
Placebo cream applied once daily to wart areas for up to 8 weeks.
Overall Number of Participants Analyzed 201 205 105
Measure Type: Number
Unit of Measure: participants
Subjects with and Adverse Reactions (ARs) 37 40 3
Subjects with Any Local Skin Reactions (LSRs) 123 148 41
Number of Subjects who Took a Rest Period 55 67 3
Time Frame One year
Adverse Event Reporting Description 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.
 
Arm/Group Title 2.5% Imiquimod Cream 3.75% Imiquimod Cream Placebo
Hide Arm/Group Description 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks. 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks. Placebo cream applied once daily to wart areas for up to 8 weeks.
All-Cause Mortality
2.5% Imiquimod Cream 3.75% Imiquimod Cream Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2.5% Imiquimod Cream 3.75% Imiquimod Cream Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/201 (1.00%)      6/205 (2.93%)      1/105 (0.95%)    
Cardiac disorders       
Chest pain * 1  0/201 (0.00%)  0 1/205 (0.49%)  1 0/105 (0.00%)  0
Endocrine disorders       
Diabetes mellitus inadequate control * 1  0/201 (0.00%)  0 1/205 (0.49%)  1 0/105 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthritis * 1  0/201 (0.00%)  0 0/205 (0.00%)  0 1/105 (0.95%)  1
Psychiatric disorders       
Anxiety * 1  0/201 (0.00%)  0 1/205 (0.49%)  1 0/105 (0.00%)  0
Suicidal ideation * 1  1/201 (0.50%)  1 0/205 (0.00%)  0 0/105 (0.00%)  0
Reproductive system and breast disorders       
Ovarian cystectomy * 1  1/201 (0.50%)  1 0/205 (0.00%)  0 0/105 (0.00%)  0
Skin and subcutaneous tissue disorders       
Malignant melanoma * 1  0/201 (0.00%)  0 2/205 (0.98%)  2 0/105 (0.00%)  0
Vascular disorders       
Diverticulitis * 1  0/201 (0.00%)  0 1/205 (0.49%)  1 0/105 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
2.5% Imiquimod Cream 3.75% Imiquimod Cream Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/201 (18.41%)      40/205 (19.51%)      3/105 (2.86%)    
General disorders       
Application site pain * 1  8/201 (3.98%)  8 16/205 (7.80%)  16 0/105 (0.00%)  0
Application site pruritus * 1  14/201 (6.97%)  14 7/205 (3.41%)  7 1/105 (0.95%)  1
Application site irritation * 1  8/201 (3.98%)  8 11/205 (5.37%)  11 1/105 (0.95%)  1
Application site rash * 1  3/201 (1.49%)  3 2/205 (0.98%)  2 0/105 (0.00%)  0
Application site ulcer * 1  3/201 (1.49%)  3 2/205 (0.98%)  2 0/105 (0.00%)  0
Application site bleeding * 1  1/201 (0.50%)  1 2/205 (0.98%)  2 1/105 (0.95%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
There was a high percentage of lost to follow up in this study. Since the disease studied in this study can be wait and watch, typically a high lost to follow up rate were seen in these kind of trials.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
a term restricts that PI can publish their trial results within 12 months of completion of the trial.
Results Point of Contact
Name/Title: Robert Babilon, Vice President, Product Development
Organization: Graceway Pharmaceuticals
Phone: 267-948-0400 ext 20428
Responsible Party: Jason Wu, MD / Executive Director, Product Development, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00735462     History of Changes
Other Study ID Numbers: GW01-0805
First Submitted: August 14, 2008
First Posted: August 15, 2008
Results First Submitted: April 24, 2011
Results First Posted: July 20, 2011
Last Update Posted: July 20, 2011