Genital Warts
Conditions
Keywords
external genital warts, perianal warts, condylomata acuminata, human papilloma virus, 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
DRUG2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas 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 types 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 Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. | Up to 16 weeks | The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 16 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2.5% Imiquimod Cream 2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks. | 202 |
| 3.75% Imiquimod Cream 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks. | 204 |
| Placebo Placebo cream applied once daily to wart areas for up to 8 weeks. | 105 |
| Total | 511 |
Baseline characteristics
| Characteristic | Total | 2.5% Imiquimod Cream | 3.75% Imiquimod Cream | Placebo |
|---|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 1 Participants | 2 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 506 Participants | 201 Participants | 201 Participants | 104 Participants |
| Age Continuous | 33.1 years STANDARD_DEVIATION 10.6 | 33.1 years STANDARD_DEVIATION 10.1 | 32.8 years STANDARD_DEVIATION 11 | 33.3 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 511 participants | 202 participants | 204 participants | 105 participants |
| Sex: Female, Male Female | 289 Participants | 117 Participants | 116 Participants | 56 Participants |
| Sex: Female, Male Male | 222 Participants | 85 Participants | 88 Participants | 49 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 | 37 / 201 | 40 / 205 | 3 / 105 |
| serious Total, serious adverse events | 2 / 201 | 6 / 205 | 1 / 105 |
Outcome results
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.
Time frame: Up to 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2.5% Imiquimod Cream | Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. | 0.248 proportion of participants |
| 3.75% Imiquimod Cream | Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. | 0.294 proportion of participants |
| Placebo | Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. | 0.09 proportion of participants |
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.
Time frame: Up to 16 weeks
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2.5% Imiquimod Cream | 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 | Subjects with Any Local Skin Reactions (LSRs) | 123 participants |
| 2.5% Imiquimod Cream | 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 | Subjects with and Adverse Reactions (ARs) | 37 participants |
| 2.5% Imiquimod Cream | 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 | Number of Subjects who Took a Rest Period | 55 participants |
| 3.75% Imiquimod Cream | 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 | Subjects with Any Local Skin Reactions (LSRs) | 148 participants |
| 3.75% Imiquimod Cream | 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 | Subjects with and Adverse Reactions (ARs) | 40 participants |
| 3.75% Imiquimod Cream | 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 | Number of Subjects who Took a Rest Period | 67 participants |
| Placebo | 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 | Subjects with and Adverse Reactions (ARs) | 3 participants |
| Placebo | 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 | Number of Subjects who Took a Rest Period | 3 participants |
| Placebo | 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 | Subjects with Any Local Skin Reactions (LSRs) | 41 participants |