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The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.
External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| imiquimod cream | Experimental | 2.5% imiquimod cream applied daily to wart area for up to 8 weeks |
|
| 3.75% imiquimod cream | Experimental | 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. |
|
| placebo cream | Placebo Comparator | placebo cream applied daily to wart areas for up to 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod | Drug | daily topical application for up to 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study | 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. | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Wu, MD | Graceway Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WILMAX Clinical Research | Mobile | Alabama | 36608 | United States | ||
| Montgomery Women's Health Associates |
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Recruitment period from June to December 2008 from 30 clinical study centers in the USA
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| ID | Title | Description |
|---|---|---|
| FG000 | 2.5% Imiquimod Cream | 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks |
| FG001 | 3.75% Imiquimod Cream | 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 3.75% imiquimod cream | Drug | 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. |
|
|
| placebo cream | Drug | placebo cream applied daily to wart areas for up to 8 weeks |
|
|
| Up to 16 weeks |
| Treatment Related Adverse Events | Numbers of subjects in each treatment group reporting one or more adverse events | Up to 16 weeks |
| Montgomery |
| Alabama |
| 36116 |
| United States |
| Women's Health Research | Phoenix | Arizona | 85015 | United States |
| Precision Trials | Phoenix | Arizona | 85032 | United States |
| Premier Pharmaceutical Research | Tempe | Arizona | 85282 | United States |
| Visions Clinical Research | Tucson | Arizona | 85712 | United States |
| Edinger Medical Group Clinical Research Center | Fountain Valley | California | 92708 | United States |
| East Bay Dermatology Medical Group | Fremont | California | 94538 | United States |
| Coastal Medical Research Group | San Luis Obispo | California | 93405 | United States |
| Torrance Clinical Research | Torrance | California | 90505 | United States |
| Clinicos, LLC | Colorado Springs | Colorado | 80904 | United States |
| Colorado Medical Research Center | Denver | Colorado | 80210 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33437 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Discovery Clinical Research | Sunrise | Florida | 33316 | United States |
| Perimeter Institute for Clinical Research | Atlanta | Georgia | 30338 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Atlanta North Gynecology | Roswell | Georgia | 30075 | United States |
| Indiana University Infectious Disease Research Group | Indianapolis | Indiana | 46202 | United States |
| Dermatology Practice | Ann Arbor | Michigan | 48103 | United States |
| Alegent Health Clinic | Omaha | Nebraska | 68124 | United States |
| Private Practice | Great Neck | New York | 11021 | United States |
| Private Practice | Purchase | New York | 10577 | United States |
| State University of NY Stony Brook | Stony Brook | New York | 11794 | United States |
| Philadelphia Institute of Dermatology | Philadelphia | Pennsylvania | 19144 | United States |
| Professional Quality Research, Women Partners in Health | Austin | Texas | 78705 | United States |
| Professional Quality Research, The Urology Team | Austin | Texas | 78759 | United States |
| University of Texas Southwestern Medical Center Dermatology Dept | Dallas | Texas | 75390 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78229 | United States |
| FG002 | Placebo | Placebo cream applied once daily to wart areas for up to 8 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2.5% Imiquimod Cream | 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks |
| BG001 | 3.75% Imiquimod Cream | 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks |
| BG002 | Placebo | Placebo cream applied once daily to wart areas for up to 8 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 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. | Posted | Number | participants | Up to 16 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study | 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. | Intention to treat | Posted | Number | 95% Confidence Interval | participants | Up to 16 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Treatment Related Adverse Events | Numbers of subjects in each treatment group reporting one or more adverse events | Patients with adverse events considered probably related or related to the administration of the product. | Posted | Number | Participants | Up to 16 weeks |
|
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2.5% Imiquimod Cream | 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks | 2 | 178 | 17 | 178 | ||
| EG001 | 3.75% Imiquimod Cream | 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks | 2 | 195 | 23 | 195 | ||
| EG002 | Placebo | Placebo cream applied once daily to wart areas for up to 8 weeks | 0 | 97 | 2 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic Mass | General disorders | MedDRA | Non-systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA | Non-systematic Assessment | Acute Surgical Abdomen |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment | Cholecystolithiasis |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment | Worsened iron deficiency anemia |
|
| Migraine | Nervous system disorders | MedDRA | Non-systematic Assessment | Worsening migraine headache |
|
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment | Syncope |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Application site irritation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Babilon, Vice President, Product Development | Graceway Pharmaceuticals | 267-948-0400 | 20428 | robert.babilon@gracewaypharma.com |
| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
| Number of Subjects with Rest Period in Treatment |
|
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|
|