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

This study has been completed.

Sponsor:

Information provided by:

Graceway Pharmaceuticals, LLC

ClinicalTrials.gov Identifier:

NCT00735462

First received: August 14, 2008

Last updated: June 21, 2011

Last verified: June 2011

History of Changes

Results First Received: April 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Genital Warts
Interventions:	Drug: 2.5% imiquimod cream Drug: 3.75% imiquimod cream Drug: Placebo cream

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	2.5% Imiquimod Cream	3.75% Imiquimod Cream	Placebo
STARTED	202	204	105
COMPLETED	139	149	77
NOT COMPLETED	63	55	28

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	2.5% Imiquimod Cream	3.75% Imiquimod Cream	Placebo	Total
Number of Participants [units: participants]	202	204	105	511
Age [units: participants]
<=18 years	1	2	0	3
Between 18 and 65 years	201	201	104	506
>=65 years	0	1	1	2
Age [units: years] Mean ± Standard Deviation	33.1 ± 10.1	32.8 ± 11.0	33.3 ± 10.8	33.1 ± 10.6
Gender [units: participants]
Female	117	116	56	289
Male	85	88	49	222
Region of Enrollment [units: participants]
United States	202	204	105	511

Outcome Measures

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1. Primary:

Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. [ Time Frame: Up to 16 weeks ]

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2. Secondary:

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 [ Time Frame: Up to 16 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	One year
Additional 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.

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

	Description
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.

Other Adverse Events

	2.5% Imiquimod Cream	3.75% Imiquimod Cream	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	37/201	40/205	3/105
General disorders
Application site pain ^{* 1}
# participants affected / at risk	8/201 (3.98%)	16/205 (7.80%)	0/105 (0.00%)
# events	8	16	0
Application site pruritus ^{* 1}
# participants affected / at risk	14/201 (6.97%)	7/205 (3.41%)	1/105 (0.95%)
# events	14	7	1
Application site irritation ^{* 1}
# participants affected / at risk	8/201 (3.98%)	11/205 (5.37%)	1/105 (0.95%)
# events	8	11	1
Application site rash ^{* 1}
# participants affected / at risk	3/201 (1.49%)	2/205 (0.98%)	0/105 (0.00%)
# events	3	2	0
Application site ulcer ^{* 1}
# participants affected / at risk	3/201 (1.49%)	2/205 (0.98%)	0/105 (0.00%)
# events	3	2	0
Application site bleeding ^{* 1}
# participants affected / at risk	1/201 (0.50%)	2/205 (0.98%)	1/105 (0.95%)
# events	1	2	1

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (11.1)

More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: a term restricts that PI can publish their trial results within 12 months of completion of the trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Robert Babilon, Vice President, Product Development
Organization: Graceway Pharmaceuticals
phone: 267-948-0400 ext 20428
e-mail: robert.babilon@gracewaypharma.com

No publications provided

Responsible Party:	Jason Wu, MD / Executive Director, Product Development, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00735462 History of Changes
Other Study ID Numbers:	GW01-0805
Study First Received:	August 14, 2008
Results First Received:	April 24, 2011
Last Updated:	June 21, 2011
Health Authority:	United States: Food and Drug Administration

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