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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 |
|---|---|---|---|
| 2.5% imiquimod cream | Experimental | 2.5% imiquimod cream applied daily to wart areas 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 |
|---|---|---|---|---|
| 2.5% imiquimod cream | Drug | 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. | The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas. | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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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 |
|---|---|---|---|---|---|---|
| NEA Clinic | Jonesboro | Arkansas | 72401 | United States | ||
| Northern Claifornia Research |
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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 |
| Carmichael |
| California |
| 95608 |
| United States |
| California State University - Chico | Chico | California | 95929 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Conant Foundation | San Francisco | California | 94114 | United States |
| Downtown Women's Healthcare | Denver | Colorado | 80218 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| PMI Health Research Group | Atlanta | Georgia | 30312 | United States |
| Atlanta Women's Research Institute | Atlanta | Georgia | 30342 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 61614 | United States |
| Howard Brown | Chicago | Illinois | 60613 | United States |
| Valley Medical Center | Flint | Michigan | 48507 | United States |
| Women's OB/GYN | Saginaw | Michigan | 48604 | United States |
| Clayton Research Institute | St Louis | Missouri | 63107 | United States |
| Women's Health Research Center | Lawrenceville | New Jersey | 08648 | United States |
| Alliance Women's Research | Riverside Park | New Jersey | 08075 | United States |
| Southwest Clinical Research | Albuquerque | New Mexico | 87102 | United States |
| University Urology Associates | New York | New York | 10016 | United States |
| Boro Park ObGyn | New York | New York | 10121 | United States |
| Crescent Medical Research | Salisbury | North Carolina | 28144 | United States |
| Piedmont Medical Research | Winston-Salem | North Carolina | 27103 | United States |
| Rapid Medical Research | Cleveland | Ohio | 44122 | United States |
| Complete Healthcare for Women | Columbus | Ohio | 43213 | United States |
| Wright State University | Dayton | Ohio | 45408 | United States |
| Heartland Health Institute | Tulsa | Oklahoma | 74105 | United States |
| Clinical Trials of America | Eugene | Oregon | 97401 | United States |
| Westover Heights Clinic | Portland | Oregon | 97210 | United States |
| The Clinical Trial Center | Jenkintown | Pennsylvania | 19046 | United States |
| Palmetto Clinical Research | Greer | South Carolina | 29650 | United States |
| Alpha Clinical Research | Clarksville | Tennessee | 37043 | United States |
| Adams Patterson Gynecology and Obstetrics | Memphis | Tennessee | 38102 | United States |
| Tennessee Women's Care | Nashville | Tennessee | 37203 | United States |
| DiscoveResearch | Bryan | Texas | 77802 | United States |
| TMC Life Research | Houston | Texas | 77054 | United States |
| West Houston Clinical Research Services | Houston | Texas | 77055 | United States |
| Urology San Antonio Research | San Antonio | Texas | 78229 | United States |
| The Center for Clinical Studies | Webster | Texas | 77058 | United States |
| Utah Clinical Trials | Salt Lake City | Utah | 84107 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| CARE-ID | Annandale | Virginia | 22003 | United States |
| Tidewater Clinical Reseach | Virginia Beach | Virginia | 23456 | United States |
| Independence Family Medicine Clinical Research | Virginia Beach | Virginia | 23513 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. | The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas. | Posted | Apr 2011 | Number | 95% Confidence Interval | proportion of participants | Up to 16 weeks |
|
|
| |||||||||||||||||||||||||||||||
| 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 | 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. | 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. | Posted | Apr 2011 | Number | participants | Up to 16 weeks |
|
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.
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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 | 201 | 37 | 201 | ||
| EG001 | 3.75% Imiquimod Cream | 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks. | 6 | 205 | 40 | 205 | ||
| EG002 | Placebo | Placebo cream applied once daily to wart areas for up to 8 weeks. | 1 | 105 | 3 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant melanoma | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Ovarian cystectomy | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diverticulitis | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Endocrine disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Application site rash | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Application site ulcer | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Application site bleeding | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
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.
a term restricts that PI can publish their trial results within 12 months of 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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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|