External Anogenital Warts
Conditions
Brief summary
A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations
Detailed description
This is a multicenter, parallel group, randomized, double-blind, placebo-controlled, trial with clinical endpoint comparing Podofilox Topical Gel 0.5% to Condylox® Gel 0.5% and a matching placebo. The study will be conducted among adult male and female patients with external anogenital warts. The Investigator will assess vital signs and perform physical examination identifying any clinically significant abnormalities. Laboratory samples will be collected, including HIV, Hepatitis B&C, and urine pregnancy tests (UPT) for women of childbearing potential. The Investigator will confirm the diagnosis of External Anogenital Warts (EAW) and the absence of contraindications specified in the exclusion criterion 4 during the visual examination. The biopsy of skin lesions will be performed per the discretion of the Investigator for microscopic verification of the diagnosis of EAWs if any doubts of the diagnosis.
Interventions
DRUGPodofilox Gel 0.5%
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
DRUGCondylox Topical Gel 0.5%
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
DRUGPlacebo Gel
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Sponsors
bioRASI, LLC
Dermax SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide written informed consent prior to participating in this study. 2. Male or female subjects, aged 18-65 inclusive, with a clinical diagnosis of external anogenital warts (i.e., perianal warts and/or external genital warts), including two or more distinct external genital warts, and wart area that is equal or less than 10 cm2. Histological confirmation should be obtained if there is any doubt of the diagnosis. 3. Females of childbearing potential may be enrolled if they practice a method of birth control with a reliability of at least 90%. 4. Sexually active study participants must agree to abstain from sexual activity of any kind throughout the treatment period to prevent cross- and reinfection by HPV. 5. Any female subject with childbearing potential has a negative urine pregnancy test at Baseline. 6. Negative HIV test within 4 weeks before Baseline.
Exclusion criteria
7. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. 8. Hypersensitivity or intolerance to Podofilox or any component of the formulation. 9. History of previous unsuccessful treatment with any formulation of Podofilox. 10. Wart area that is greater than 10 cm2. 11. Patients with internal anogenital and mucous membrane warts, Bowenoid papulosis, squamous cell carcinoma, active herpes lesion, or other skin abnormalities of treatment area, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar). 12. Primary or secondary immunodeficiency. 13. Known presence of diabetes type I or II. 14. Local irritation in any treatment area that would interfere with treatment. 15. Use within 4 weeks prior to baseline of any: 1) treatment for anogenital warts, 2) systemic corticosteroids, or 3) systemic immunosuppressive drug. 16. Any medical or surgical condition in the judgment of the Investigator that may interfere with the assessment of efficacy or safety, or pose a risk to the subject. 17. Patients known to abuse alcohol and/or drugs, or with a history of chronic alcohol or drug abuse that may result in protocol noncompliance. 18. Received another investigational drug, device or biologic within 90 days prior to the start of Screening or has planned to participate in another clinical trial while enrolled in this study. 19. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study 20. Employee (or employee's family member) of the research center or private practice, CRO or Sponsor, or subjects who have a conflict of interest. 21. Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be enrolled in the study at the same time. 22. Previous enrollment in this study, current enrollment in this study at another participating site or current enrollment in another study (in parallel to this study) at another clinical research site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | 28 days. | The primary endpoint is the Number and Percentage of subjects in the per protocol (PP) population with treatment success defined as total disappearance of all warts within all treated areas. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | 28 days (at visit 6) | Local application site reactions scores (erythema, dryness, burning/stinging, erosion, edema, pain, itching and bleeding) in each group during the study drug application period. Other adverse events including serious adverse events throughout the study participation. Local skin reaction scores for erythema, dryness, burning/stinging, erosion, edema, pain, itching and bleeding will be recorded by the Investigator for every study visit based on their intensity. Skin Reaction Scale will be used absent, mild (slight, barely perceptible), moderate (distinct presence) and severe (marked, intense). |
| Analysis of Safety Variables Will be Based on All Adverse Events (AE). | The AE reporting period for this study begins with the signature of the Informed Consent Form and, for unresolved AEs, ends 30 days following the last study medication application, a total of up to 65 days. | AEs will be summarized based on the frequency of AEs and their severity for all treated subjects. |
Countries
Russia, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Podofilox Gel 0.5 % Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles
Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles | 201 |
| Condylox Topical Gel 0.5% Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles
Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles | 198 |
| Placebo Gel Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient
Placebo Gel: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles | 67 |
| Total | 466 |
Baseline characteristics
| Characteristic | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 201 Participants | 198 Participants | 67 Participants | 466 Participants |
| Age, Continuous | 35.6 years STANDARD_DEVIATION 12.745 | 37.7 years STANDARD_DEVIATION 11.24 | 32.3 years STANDARD_DEVIATION 10.401 | 34.7 years STANDARD_DEVIATION 11.705 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 38 Participants | 17 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 165 Participants | 160 Participants | 50 Participants | 375 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 14 Participants | 5 Participants | 38 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized other | 4 Participants | 4 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 176 Participants | 180 Participants | 62 Participants | 418 Participants |
| Sex: Female, Male Female | 85 Participants | 83 Participants | 28 Participants | 196 Participants |
| Sex: Female, Male Male | 116 Participants | 115 Participants | 39 Participants | 270 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 201 | 0 / 198 | 0 / 67 |
| other Total, other adverse events | 105 / 201 | 114 / 198 | 33 / 67 |
| serious Total, serious adverse events | 0 / 201 | 1 / 198 | 0 / 67 |
Outcome results
Primary
Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas.
The primary endpoint is the Number and Percentage of subjects in the per protocol (PP) population with treatment success defined as total disappearance of all warts within all treated areas.
Time frame: 28 days.
Population: Due to GCP non-compliance in site 201, two sets of Efficacy Analysis were generated: Definitive Efficacy Analysis Set excluding site 201 and Supplemental Efficacy Analysis Set including site 201. Analysis using Definitive Efficacy Analysis Set (without site 201) were considered definitive for bioequivalence. The same analyses were performed using supplemental efficacy analysis set (sensitivity analysis) and these analyses were considered supportive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Podofilox Gel 0.5 % | Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | 100 Participants |
| Condylox Topical Gel 0.5% | Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | 102 Participants |
| Placebo Gel | Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | 12 Participants |
90% CI: [-12, 7]
Secondary
Analysis of Safety Variables Will be Based on All Adverse Events (AE).
AEs will be summarized based on the frequency of AEs and their severity for all treated subjects.
Time frame: The AE reporting period for this study begins with the signature of the Informed Consent Form and, for unresolved AEs, ends 30 days following the last study medication application, a total of up to 65 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Related TESAE | 0 Participants |
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TEAE Leading to Discontinuation | 1 Participants |
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Related TEAE | 102 Participants |
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TESAE | 0 Participants |
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TEAE Leading to Death | 0 Participants |
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of subjects with at least One TEAE | 105 Participants |
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Severe TESAE | 0 Participants |
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Severe TEAE | 4 Participants |
| Podofilox Gel 0.5 % | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TESAE Leading to Discontinuation | 0 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TESAE Leading to Discontinuation | 1 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of subjects with at least One TEAE | 114 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Related TEAE | 105 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Severe TEAE | 1 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TEAE Leading to Discontinuation | 1 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TEAE Leading to Death | 0 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TESAE | 1 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Related TESAE | 1 Participants |
| Condylox Topical Gel 0.5% | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Severe TESAE | 1 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TESAE | 0 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Severe TEAE | 0 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of subjects with at least One TEAE | 33 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Related TESAE | 0 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Related TEAE | 29 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TESAE Leading to Discontinuation | 0 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TEAE Leading to Death | 0 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One TEAE Leading to Discontinuation | 0 Participants |
| Placebo Gel | Analysis of Safety Variables Will be Based on All Adverse Events (AE). | Number of Subjects with at Least One Severe TESAE | 0 Participants |
Secondary
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Local application site reactions scores (erythema, dryness, burning/stinging, erosion, edema, pain, itching and bleeding) in each group during the study drug application period. Other adverse events including serious adverse events throughout the study participation. Local skin reaction scores for erythema, dryness, burning/stinging, erosion, edema, pain, itching and bleeding will be recorded by the Investigator for every study visit based on their intensity. Skin Reaction Scale will be used absent, mild (slight, barely perceptible), moderate (distinct presence) and severe (marked, intense).
Time frame: 28 days (at visit 6)
Population: Safety Population, 266 subjects completed the study at visit 6 (Podofilox Gel 0.5%: 114 subjects; Condylox Topical Gel 0.5%: 102 subjects and Placebo gel: 50 subjects).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Mild | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Moderate | 2 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Severe | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Severe | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Severe | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Absent | 108 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Absent | 114 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Absent | 112 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Moderate | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Severe | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Mild | 2 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Moderate | 2 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Absent | 111 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Moderate | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Mild | 4 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Severe | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Mild | 9 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Moderate | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Absent | 102 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Severe | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Absent | 114 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Moderate | 2 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Mild | 3 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Mild | 1 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Severe | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Mild | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Absent | 111 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Absent | 111 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Severe | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Moderate | 0 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Mild | 1 Participants |
| Podofilox Gel 0.5 % | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Moderate | 3 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Severe | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Mild | 14 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Moderate | 7 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Severe | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Absent | 94 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Mild | 7 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Moderate | 1 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Severe | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Absent | 92 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Mild | 5 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Moderate | 5 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Severe | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Absent | 97 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Mild | 2 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Moderate | 3 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Severe | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Absent | 98 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Mild | 4 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Moderate | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Moderate | 2 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Severe | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Absent | 102 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Absent | 81 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Absent | 99 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Mild | 3 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Severe | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Moderate | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Moderate | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Absent | 94 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Mild | 6 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Severe | 0 Participants |
| Condylox Topical Gel 0.5% | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Mild | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Severe | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Severe | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Absent | 48 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Absent | 50 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Moderate | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Mild | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Severe | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Mild | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erosion | Absent | 50 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Severe | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Severe | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Absent | 50 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Pain | Moderate | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Severe | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Moderate | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Severe | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Absent | 49 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Moderate | 1 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Mild | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Bleeding | Moderate | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Burning/Stinging | Mild | 1 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Mild | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Moderate | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Itching | Mild | 1 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Absent | 45 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Mild | 4 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Moderate | 1 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Moderate | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Erythema | Severe | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Mild | 0 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Dryness | Absent | 50 Participants |
| Placebo Gel | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Edema | Absent | 50 Participants |