Warts
Conditions
Keywords
Verruca vulgaris, Common Warts
Brief summary
This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the exception of unblinded dedicated staff to handle study medication), phase 2a study with 3 dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20 weeks (10 doses administered every other week) or until a subject has complete resolution of all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for evidence of new or reoccurring warts and for safety evaluation.
Interventions
BIOLOGICALCANDIN
Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OTHERPlacebo
0.9% Sodium Chloride Injection USP (non-preserved)
Sponsors
Nielsen BioSciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women between the ages of 18 and 65 years inclusively at time of consent 2. Subjects presenting with 3 to 20 injectable common warts (verruca vulgaris) for at least 12 weeks at the time of the Baseline Visit 3. Subject's common warts for injection must measure between 3 and 20 mm at Baseline Visit and be located on hands, feet (excluding soles), limbs, and/or trunk. Flat, plantar, facial, periungual, genital warts or warts in region of pre-existing inflammatory condition are excluded from injection 4. Subjects enrolled into Cohort 3 must have common warts for injection in at least 2 different anatomical regions defined as: left arm, right arm, left hand, right hand, left leg, right leg, left foot (excluding sole), right foot (excluding sole) and torso 5. Subject, male or female is willing to use effective contraceptive method for at least 30 days before the Baseline Visit and at least 30 days after the last study drug administration unless not of childbearing potential as defined as post-menopausal for at least 2 years (females) or surgically sterile (tubal ligation, oophorectomy, or hysterectomy for females, and vasectomy for males). The only contraceptive use exceptions would be individuals in exclusive same sex partnerships and individuals who agree to remain non-sexually active for the duration of the study. Acceptable contraceptive methods for subjects include: * Barrier methods, such as condom, sponge or diaphragm, combined with spermicide in foam, gel or cream; * Hormonal contraception (oral, intramuscular, implant or transdermal which includes Depo-Provera, Evra and Nuvaring); * Intrauterine device (IUD) 6. Mentally and legally capable of giving informed consent prior to any study related procedures
Exclusion criteria
1. Presence of systemic or localized diseases, conditions, or medications that could interfere with assessment of safety and efficacy or that compromise immune function including psoriasis 2. Subject has been diagnosed with diabetes mellitus 3. Subject has a history of keloid formation 4. Injectable common wart(s) located in areas with existing dermatologic conditions (such as psoriasis) or with an underlying inflammatory conditions (such as arthritic joints), or tattoos or implants/piercing/hardware or marking that may conceal responses or reactions are excluded from injection 5. Existing/planned pregnancy, childbirth in the past six months prior to the Baseline Visit, or breast feeding, or plan on donating eggs or sperm during the study and in the month following the last injection 6. Treatment of warts with liquid nitrogen, carbon dioxide, electrodessication, laser, surgery, simple occlusion (e.g. duct tape) salicylic or related acids, OTC treatments, cantharidin, or other treatments within 4 weeks of the Baseline Visit 7. Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil, bleomycin, podophyllin or any other wart immunotherapy or treatment designed to stimulate immune response (except for treatments already listed in exclusion criterion 6) within 12 weeks of the Baseline Visit 8. Recalcitrant warts defined as those not successfully treated by 5 or more treatments (excluding OTC treatments) 9. Abnormal (low \< 5 mm or high \>25 mm) baseline result to the Delayed Type Hypersensitivity (DTH) test 10. Subject has a condition or treatment resulting in being immunocompromised 11. Systemic treatment (such as oral or injected) with cimetidine, zinc supplements at a dose higher than 20 mg of elemental zinc daily or an immunosuppressive drug (such as: azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids, etc.) within 12 weeks of the Baseline Visit 12. Subject has used any investigational agent within 30 days prior to the Baseline Visit or within 5 half-lives of that investigational agent prior to the Baseline Visit (whichever is longer) 13. Previous treatment of warts with any type of intralesional injection with candida extract (including CANDIN)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit | 45 weeks | Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s) | 45 weeks | Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart |
| Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts | 45 weeks | — |
| Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s) | 45 weeks | Scarring at any visit, many reports were transient being noted at only one or two visits and noted as resolving during the course of the study |
| Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s) | 45 weeks | — |
| Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | 45 weeks | — |
| Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit | 45 weeks | Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart |
| Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit | 4 month follow up visit at 45 weeks | Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart |
| Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s) | 45 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | 45 weeks | Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart |
| The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | 45 weeks | — |
| Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart | 45 weeks | Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart |
| Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit. | 45 weeks | — |
Countries
United States
Participant flow
Pre-assignment details
Screen Fail Rate of 30% - 12% due to warts not meeting criteria, 12% due to DTH measurement not meeting criteria, 5% other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo 0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
Placebo: 0.9% Sodium Chloride Injection USP (non-preserved) | 43 |
| Cohort 1 0.3 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity | 44 |
| Cohort 2 0.5 mL of CANDIN administered intralesionally in the largest common wart
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity | 39 |
| Cohort 3 0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)
CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity | 40 |
| Total | 166 |
Baseline characteristics
| Characteristic | Cohort 3 | Cohort 2 | Cohort 1 | Total | Pooled Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 30.2 years | 33.5 years | 35.6 years | 33.6 years | 34.7 years |
| Age of Primary Injected Wart(s) | 196.8 weeks | 174.7 weeks | 202.0 weeks | 201.3 weeks | 228.9 weeks |
| Area of Primary Injected Wart | 27.66 mm^2 | 36.95 mm^2 | 41.47 mm^2 | 34.68 mm^2 | 32.19 mm^2 |
| Body Mass Index | 27.42 kg/m2 STANDARD_DEVIATION 7.486 | 27.85 kg/m2 STANDARD_DEVIATION 6.461 | 29.11 kg/m2 STANDARD_DEVIATION 6.291 | 28.83 kg/m2 STANDARD_DEVIATION 7.392 | 30.75 kg/m2 STANDARD_DEVIATION 8.812 |
| Body Weight | 83.27 kg STANDARD_DEVIATION 21.929 | 81.77 kg STANDARD_DEVIATION 18.977 | 90.30 kg STANDARD_DEVIATION 22.753 | 87.54 kg STANDARD_DEVIATION 23.629 | 93.91 kg STANDARD_DEVIATION 28.165 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 5 Participants | 19 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 35 Participants | 39 Participants | 147 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Location of Common Warts Left Arm | 5 each | 1 each | 4 each | 16 each | 6 each |
| Location of Common Warts Left Foot (excluding sole) | 2 each | 3 each | 0 each | 6 each | 1 each |
| Location of Common Warts Left Hand | 35 each | 25 each | 21 each | 110 each | 29 each |
| Location of Common Warts Left Leg | 5 each | 3 each | 1 each | 12 each | 3 each |
| Location of Common Warts Right Arm | 2 each | 3 each | 7 each | 12 each | 0 each |
| Location of Common Warts Right Foot (excluding sole) | 2 each | 1 each | 0 each | 6 each | 3 each |
| Location of Common Warts Right Hand | 37 each | 26 each | 36 each | 135 each | 36 each |
| Location of Common Warts Right Leg | 1 each | 3 each | 1 each | 9 each | 4 each |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 0 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 3 Participants | 7 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 30 Participants | 40 Participants | 148 Participants | 41 Participants |
| Region of Enrollment United States | 40 participants | 39 participants | 44 participants | 166 participants | 43 participants |
| Response (size of induration) to CANDIN injection during screening | 10.30 mm STANDARD_DEVIATION 3.902 | 11.01 mm STANDARD_DEVIATION 4.534 | 12.09 mm STANDARD_DEVIATION 5.672 | 10.85 mm STANDARD_DEVIATION 4.661 | 9.95 mm STANDARD_DEVIATION 4.116 |
| Sex: Female, Male Female | 11 Participants | 24 Participants | 17 Participants | 68 Participants | 16 Participants |
| Sex: Female, Male Male | 29 Participants | 15 Participants | 27 Participants | 98 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 45 | 0 / 40 | 0 / 41 |
| other Total, other adverse events | 32 / 43 | 33 / 45 | 34 / 40 | 33 / 41 |
| serious Total, serious adverse events | 0 / 43 | 0 / 45 | 2 / 40 | 1 / 41 |
Outcome results
Primary
Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 45 weeks
Population: Modified Intent to Treat (mITT) - subjects that received at least one post baseline measurement of the primary wart(s)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit | 16 Participants |
| Cohort 1 | Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit | 29 Participants |
| Cohort 2 | Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit | 31 Participants |
| Cohort 3 | Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit | 29 Participants |
p-value: 0.032995% CI: [1.0184, 2.4223]Cochran-Mantel-Haenszel
p-value: 0.000795% CI: [1.2722, 2.8156]Cochran-Mantel-Haenszel
p-value: 0.005295% CI: [1.1602, 2.5854]Cochran-Mantel-Haenszel
Secondary
Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)
Time frame: 45 weeks
Population: mITT - Subjects that received at least one post baseline measurement of the primary wart(s)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pooled Placebo | Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s) | 9.0 injection visits |
| Cohort 1 | Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s) | 3.0 injection visits |
| Cohort 2 | Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s) | 2.0 injection visits |
| Cohort 3 | Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s) | 2.0 injection visits |
Secondary
Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 45 weeks
Population: mITT. Subjects that received at least one post baseline measurement of the primary wart(s). Cohort 3 values represent resolution of largest primary wart
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pooled Placebo | Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s) | 10 injection visits |
| Cohort 1 | Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s) | 5 injection visits |
| Cohort 2 | Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s) | 5 injection visits |
| Cohort 3 | Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s) | 4 injection visits |
p-value: 0.002795% CI: [1.4211, 5.3419]Regression, Cox
p-value: 0.000895% CI: [1.6148, 6.1509]Regression, Cox
p-value: 0.000395% CI: [1.7263, 6.407]Regression, Cox
Secondary
Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts
Time frame: 45 weeks
Population: mITT - Subjects that received at least on post baseline measurement of the primary wart(s)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pooled Placebo | Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts | 10.0 injection visits |
| Cohort 1 | Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts | 5.0 injection visits |
| Cohort 2 | Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts | 4.0 injection visits |
| Cohort 3 | Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts | 3.0 injection visits |
Secondary
Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 45 weeks
Population: mITT - Subjects that received at least one post baseline measurement of the primary wart(s)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit | 7 Participants |
| Cohort 1 | Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit | 12 Participants |
| Cohort 2 | Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit | 20 Participants |
| Cohort 3 | Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit | 12 Participants |
p-value: 0.430795% CI: [0.6191, 3.0883]Cochran-Mantel-Haenszel
p-value: 0.001495% CI: [1.4169, 5.8978]Cochran-Mantel-Haenszel
p-value: 0.045195% CI: [0.9281, 9.6975]Cochran-Mantel-Haenszel
Secondary
Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 4 month follow up visit at 45 weeks
Population: mITT - Subjects that received at least one post baseline measurement of the primary wart(s)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit | 16 Participants |
| Cohort 1 | Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit | 20 Participants |
| Cohort 2 | Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit | 27 Participants |
| Cohort 3 | Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit | 20 Participants |
Secondary
Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)
Time frame: 45 weeks
Population: Only mITT subjects with complete resolution of warts included in this endpoint
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s) | 0 Participants |
| Cohort 1 | Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s) | 1 Participants |
| Cohort 2 | Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s) | 1 Participants |
| Cohort 3 | Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s) | 2 Participants |
Secondary
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Time frame: 45 weeks
Population: Safety Population- All randomized subjects who received at least one intralesional dose of study medication. Subjects experiencing multiple types of reactions were counted once for each type, but only once across all reactions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled Placebo | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Tenderness | 27 participants |
| Pooled Placebo | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Peeling | 1 participants |
| Pooled Placebo | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Erythema/Redness | 3 participants |
| Pooled Placebo | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Pain | 15 participants |
| Pooled Placebo | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Scarring | 1 participants |
| Pooled Placebo | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Pruritis/Itching | 13 participants |
| Pooled Placebo | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Edema/Swelling | 9 participants |
| Cohort 1 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Peeling | 3 participants |
| Cohort 1 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Edema/Swelling | 17 participants |
| Cohort 1 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Pruritis/Itching | 36 participants |
| Cohort 1 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Erythema/Redness | 18 participants |
| Cohort 1 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Scarring | 6 participants |
| Cohort 1 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Pain | 41 participants |
| Cohort 1 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Tenderness | 42 participants |
| Cohort 2 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Edema/Swelling | 27 participants |
| Cohort 2 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Tenderness | 40 participants |
| Cohort 2 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Pain | 35 participants |
| Cohort 2 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Pruritis/Itching | 32 participants |
| Cohort 2 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Erythema/Redness | 25 participants |
| Cohort 2 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Peeling | 2 participants |
| Cohort 2 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Scarring | 2 participants |
| Cohort 3 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Pruritis/Itching | 33 participants |
| Cohort 3 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Scarring | 2 participants |
| Cohort 3 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Peeling | 8 participants |
| Cohort 3 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Pain | 39 participants |
| Cohort 3 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Tenderness | 39 participants |
| Cohort 3 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Erythema/Redness | 23 participants |
| Cohort 3 | Number of Subjects With Injection Site Reactions With Frequency Greater Than 5% | Edema/Swelling | 23 participants |
Secondary
Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)
Scarring at any visit, many reports were transient being noted at only one or two visits and noted as resolving during the course of the study
Time frame: 45 weeks
Population: mITT - Subjects that received at least one post baseline measurement of the primary wart(s)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s) | 1 Participants |
| Cohort 1 | Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s) | 7 Participants |
| Cohort 2 | Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s) | 3 Participants |
| Cohort 3 | Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s) | 3 Participants |
Other Pre-specified
Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 45 weeks
Population: mITT- Subjects that received at least one post baseline measurement of the primary wart(s)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled Placebo | Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart | 18 number of warts resolved |
| Cohort 1 | Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart | 29 number of warts resolved |
| Cohort 2 | Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart | 31 number of warts resolved |
| Cohort 3 | Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart | 29 number of warts resolved |
Comparison: Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.p-value: 0.482495% CI: [0.997, 1.001]Regression, Logistic
Comparison: Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.p-value: 0.500795% CI: [0.998, 1.004]Regression, Logistic
Comparison: Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.p-value: 0.021995% CI: [0.987, 0.999]Regression, Logistic
Comparison: Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.p-value: 0.826795% CI: [0.995, 1.004]Regression, Logistic
Other Pre-specified
Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit.
Time frame: 45 weeks
Population: mITT - subjects that received at least one post baseline measurement of the primary wart(s)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled Placebo | Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit. | 5 wart recurrences |
| Cohort 1 | Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit. | 14 wart recurrences |
| Cohort 2 | Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit. | 13 wart recurrences |
| Cohort 3 | Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit. | 24 wart recurrences |
Comparison: Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.p-value: 0.165795% CI: [0.915, 1.015]Regression, Logistic
Comparison: Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.p-value: 0.816895% CI: [0.997, 1.003]Regression, Logistic
Comparison: Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.p-value: 0.418395% CI: [0.993, 1.003]Regression, Logistic
Comparison: Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.p-value: 0.557295% CI: [0.997, 1.006]Regression, Logistic
Other Pre-specified
Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 45 weeks
Population: mITT- Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Salicylic acid | 1 Participants |
| Pooled Placebo | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Surgery | 0 Participants |
| Pooled Placebo | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Cryotherapy | 6 Participants |
| Pooled Placebo | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Other | 0 Participants |
| Pooled Placebo | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Naive | 12 Participants |
| Cohort 1 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Surgery | 1 Participants |
| Cohort 1 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Naive | 24 Participants |
| Cohort 1 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Cryotherapy | 27 Participants |
| Cohort 1 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Salicylic acid | 12 Participants |
| Cohort 1 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Other | 1 Participants |
| Cohort 2 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Other | 3 Participants |
| Cohort 2 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Salicylic acid | 6 Participants |
| Cohort 2 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Naive | 11 Participants |
| Cohort 2 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Surgery | 0 Participants |
| Cohort 2 | Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History | Cryotherapy | 17 Participants |
Other Pre-specified
The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts
Time frame: 45 weeks
Population: mITT - Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled Placebo | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Salicylic Acid | 0 Number of warts |
| Pooled Placebo | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Surgery | 0 Number of warts |
| Pooled Placebo | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Naive | 2 Number of warts |
| Pooled Placebo | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Cryotherapy | 0 Number of warts |
| Pooled Placebo | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Other | 0 Number of warts |
| Cohort 1 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Surgery | 0 Number of warts |
| Cohort 1 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Naive | 11 Number of warts |
| Cohort 1 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Cryotherapy | 13 Number of warts |
| Cohort 1 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Salicylic Acid | 7 Number of warts |
| Cohort 1 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Other | 0 Number of warts |
| Cohort 2 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Other | 0 Number of warts |
| Cohort 2 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Salicylic Acid | 2 Number of warts |
| Cohort 2 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Naive | 3 Number of warts |
| Cohort 2 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Surgery | 0 Number of warts |
| Cohort 2 | The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts | Cryotherapy | 4 Number of warts |