Trial Outcomes & Findings for Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts (NCT NCT03532776)
NCT ID: NCT03532776
Last Updated: 2021-07-27
Results Overview
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".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
466 participants
Primary outcome timeframe
28 days.
Results posted on
2021-07-27
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
201
|
198
|
67
|
|
Overall Study
COMPLETED
|
196
|
194
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts
Baseline characteristics by cohort
| Measure |
Podofilox Gel 0.5 %
n=201 Participants
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
|
Condylox Topical Gel 0.5%
n=198 Participants
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
|
Placebo Gel
n=67 Participants
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
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
201 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
466 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 12.745 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 11.24 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 10.401 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 11.705 • n=4 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
375 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
176 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
418 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
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".
Outcome measures
| Measure |
Podofilox Gel 0.5 %
n=155 Participants
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
|
Condylox Topical Gel 0.5%
n=153 Participants
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
|
Placebo Gel
n=52 Participants
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
|
|---|---|---|---|
|
Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas.
|
100 Participants
|
102 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
Podofilox Gel 0.5 %
n=114 Participants
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
|
Condylox Topical Gel 0.5%
n=102 Participants
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
|
Placebo Gel
n=50 Participants
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
|
|---|---|---|---|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Dryness · Absent
|
111 Participants
|
94 Participants
|
50 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Dryness · Mild
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Dryness · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Dryness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Burning/Stinging · Absent
|
108 Participants
|
92 Participants
|
48 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Burning/Stinging · Mild
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Burning/Stinging · Moderate
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Burning/Stinging · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Erosion · Absent
|
111 Participants
|
97 Participants
|
50 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Erosion · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Erosion · Moderate
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Erosion · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Edema · Absent
|
112 Participants
|
98 Participants
|
50 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Edema · Mild
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Edema · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Edema · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Pain · Absent
|
114 Participants
|
99 Participants
|
50 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Pain · Mild
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Itching · Absent
|
111 Participants
|
94 Participants
|
49 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Itching · Mild
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Itching · Moderate
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Itching · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Bleeding · Absent
|
114 Participants
|
102 Participants
|
50 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Bleeding · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Bleeding · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Bleeding · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Erythema · Absent
|
102 Participants
|
81 Participants
|
45 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Erythema · Mild
|
9 Participants
|
14 Participants
|
4 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Erythema · Moderate
|
3 Participants
|
7 Participants
|
1 Participants
|
|
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Erythema · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Podofilox Gel 0.5 %
n=201 Participants
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
|
Condylox Topical Gel 0.5%
n=198 Participants
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
|
Placebo Gel
n=67 Participants
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
|
|---|---|---|---|
|
Analysis of Safety Variables Will be Based on All Adverse Events (AE).
Number of subjects with at least One TEAE
|
105 Participants
|
114 Participants
|
33 Participants
|
|
Analysis of Safety Variables Will be Based on All Adverse Events (AE).
Number of Subjects with at Least One Related TEAE
|
102 Participants
|
105 Participants
|
29 Participants
|
|
Analysis of Safety Variables Will be Based on All Adverse Events (AE).
Number of Subjects with at Least One Severe TEAE
|
4 Participants
|
1 Participants
|
0 Participants
|
|
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
|
1 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
|
Analysis of Safety Variables Will be Based on All Adverse Events (AE).
Number of Subjects with at Least One TESAE
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Analysis of Safety Variables Will be Based on All Adverse Events (AE).
Number of Subjects with at Least One Related TESAE
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Analysis of Safety Variables Will be Based on All Adverse Events (AE).
Number of Subjects with at Least One Severe TESAE
|
0 Participants
|
1 Participants
|
0 Participants
|
|
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
|
1 Participants
|
0 Participants
|
Adverse Events
Podofilox Gel 0.5 %
Serious events: 0 serious events
Other events: 105 other events
Deaths: 0 deaths
Condylox Topical Gel 0.5%
Serious events: 1 serious events
Other events: 114 other events
Deaths: 0 deaths
Placebo Gel
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Podofilox Gel 0.5 %
n=201 participants at risk
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
|
Condylox Topical Gel 0.5%
n=198 participants at risk
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
|
Placebo Gel
n=67 participants at risk
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
|
|---|---|---|---|
|
General disorders
Application Site Necrosis
|
0.00%
0/201 • 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.
|
0.51%
1/198 • Number of events 1 • 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.
|
0.00%
0/67 • 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.
|
Other adverse events
| Measure |
Podofilox Gel 0.5 %
n=201 participants at risk
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
|
Condylox Topical Gel 0.5%
n=198 participants at risk
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
|
Placebo Gel
n=67 participants at risk
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
|
|---|---|---|---|
|
General disorders
Application site erythema
|
34.3%
69/201 • 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.
|
39.9%
79/198 • 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.
|
29.9%
20/67 • 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.
|
|
General disorders
Application site pain
|
25.9%
52/201 • 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.
|
28.3%
56/198 • 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.
|
23.9%
16/67 • 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.
|
|
General disorders
Application site pruritus
|
11.9%
24/201 • 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.
|
13.1%
26/198 • 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.
|
10.4%
7/67 • 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.
|
|
General disorders
Application site dryness
|
9.5%
19/201 • 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.
|
8.6%
17/198 • 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.
|
6.0%
4/67 • 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.
|
|
General disorders
Application site erosion
|
3.0%
6/201 • 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.
|
5.1%
10/198 • 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.
|
7.5%
5/67 • 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.
|
|
General disorders
Application site haemorrhage
|
1.00%
2/201 • 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.
|
1.0%
2/198 • 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.
|
0.00%
0/67 • 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.
|
|
General disorders
Application site necrosis
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
General disorders
Feeling hot
|
0.50%
1/201 • 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.
|
0.00%
0/198 • 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.
|
0.00%
0/67 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
4/201 • 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.
|
2.0%
4/198 • 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.
|
1.5%
1/67 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
3/201 • 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.
|
1.5%
3/198 • 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.
|
3.0%
2/67 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/201 • 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.
|
1.0%
2/198 • 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.
|
0.00%
0/67 • 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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Nervous system disorders
Headache
|
1.5%
3/201 • 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.
|
1.5%
3/198 • 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.
|
3.0%
2/67 • 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.
|
|
Nervous system disorders
Paraesthesia
|
0.50%
1/201 • 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.
|
0.51%
1/198 • 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.
|
1.5%
1/67 • 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.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.50%
1/201 • 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.
|
0.00%
0/198 • 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.
|
0.00%
0/67 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.50%
1/201 • 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.
|
0.00%
0/198 • 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.
|
0.00%
0/67 • 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.
|
|
Infections and infestations
Genital herpes
|
0.50%
1/201 • 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.
|
0.00%
0/198 • 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.
|
0.00%
0/67 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Renal and urinary disorders
Dysuria
|
1.00%
2/201 • 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.
|
0.00%
0/198 • 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.
|
0.00%
0/67 • 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.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.50%
1/201 • 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.
|
0.00%
0/198 • 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.
|
0.00%
0/67 • 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.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/201 • 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.
|
0.51%
1/198 • 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.
|
0.00%
0/67 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.50%
1/201 • 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.
|
0.00%
0/198 • 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.
|
0.00%
0/67 • 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.
|
|
Vascular disorders
Hyperaemia
|
0.50%
1/201 • 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.
|
0.00%
0/198 • 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.
|
0.00%
0/67 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any use of information, data or results related to, associated with and directly resulting from the Study shall only be published or presented only after providing a copy of the manuscript or presentation, at least 60 days in advance of such publication or presentation, to the Sponsor for its review and approval in writing. No Confidential Information may be published without the express written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER