Genital Warts
Conditions
Keywords
external genital warts, perianal warts, condylomata acuminata, venereal warts, HPV types 6 and 11
Brief summary
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.
Interventions
DRUGImiquimod
daily topical application for up to 8 weeks
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
DRUGplacebo cream
placebo cream applied daily to wart areas for up to 8 weeks
Sponsors
Graceway Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* In good general health * Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts * Negative pregnancy test (for women who are able to become pregnant)
Exclusion criteria
* Women who are pregnant, lactating or planning to become pregnant during the study * Evidence of clinically significant or unstable disease (such as stroke, heart attack) * Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas * Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study | Up to 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. | Up to 16 weeks | 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. |
| Treatment Related Adverse Events | Up to 16 weeks | Numbers of subjects in each treatment group reporting one or more adverse events |
Countries
United States
Participant flow
Recruitment details
Recruitment period from June to December 2008 from 30 clinical study centers in the USA
Participants by arm
| Arm | Count |
|---|---|
| 2.5% Imiquimod Cream 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks | 178 |
| 3.75% Imiquimod Cream 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks | 195 |
| Placebo Placebo cream applied once daily to wart areas for up to 8 weeks | 97 |
| Total | 470 |
Baseline characteristics
| Characteristic | 3.75% Imiquimod Cream | Placebo | 2.5% Imiquimod Cream | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 189 Participants | 91 Participants | 173 Participants | 453 Participants |
| Age Continuous | 32.5 years STANDARD_DEVIATION 11.6 | 30.5 years STANDARD_DEVIATION 10.6 | 32.7 years STANDARD_DEVIATION 11.3 | 32.2 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment United States | 195 participants | 97 participants | 178 participants | 470 participants |
| Sex: Female, Male Female | 100 Participants | 50 Participants | 95 Participants | 245 Participants |
| Sex: Female, Male Male | 95 Participants | 47 Participants | 83 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 178 | 23 / 195 | 2 / 197 |
| serious Total, serious adverse events | 2 / 178 | 2 / 195 | 0 / 97 |
Outcome results
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.
Time frame: Up to 16 weeks
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2.5% Imiquimod Cream | Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study | 0.191 participants |
| 3.75% Imiquimod Cream | Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study | 0.272 participants |
| Placebo | Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study | 0.103 participants |
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.
Time frame: Up to 16 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2.5% Imiquimod Cream | Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. | Number of Subjects with Rest Period in Treatment | 49 participants |
| 2.5% Imiquimod Cream | 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 | 110 participants |
| 2.5% Imiquimod Cream | Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. | Adverse Reactions | 27 participants |
| 3.75% Imiquimod Cream | 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 | 144 participants |
| 3.75% Imiquimod Cream | Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. | Adverse Reactions | 30 participants |
| 3.75% Imiquimod Cream | Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. | Number of Subjects with Rest Period in Treatment | 59 participants |
| Placebo | Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. | Adverse Reactions | 2 participants |
| Placebo | Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. | Number of Subjects with Rest Period in Treatment | 1 participants |
| Placebo | 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 | 29 participants |
Secondary
Treatment Related Adverse Events
Numbers of subjects in each treatment group reporting one or more adverse events
Time frame: Up to 16 weeks
Population: Patients with adverse events considered probably related or related to the administration of the product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2.5% Imiquimod Cream | Treatment Related Adverse Events | 27 Participants |
| 3.75% Imiquimod Cream | Treatment Related Adverse Events | 30 Participants |
| Placebo | Treatment Related Adverse Events | 2 Participants |