Trial Outcomes & Findings for Clinical Endpoint Study of Ivermectin 0.5% Lotion (NCT NCT03301649)

Last Updated: 2019-12-20

Results Overview

Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice \[ivermectin\] lotion 0.5%) was done in this endpoint, hence placebo group was not included.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

905 participants

Primary outcome timeframe

Day 15 ± 2

Results posted on

2019-12-20

Participant Flow

A total of 912 infested household participants were included and 911 (905 enrolled \[380 index + 525 non-index\] + 6 non-enrolled) were treated. Participants were randomized in 3:3:1 to generic ivermectin, Sklice (ivermectin), or vehicle lotion. 1 participant was considered randomized but not dispensed, so not included in any treatment arm.

Non-enrolled infested participants: Any household member who was infested with lice and agreed to be treated with study drug but did not participate in the study. 912 infested patients were available to participate in the study, one patient was not dispensed study product, 911 patients (905 enrolled + 6 non-enrolled) were treated.

Participant milestones

Participant milestones
Measure	Generic Ivermectin Lotion 0.5% Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Sklice (Ivermectin) Lotion Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Vehicle Lotion Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
Overall Study STARTED	399	400	112
Overall Study Safety Population	399	400	112
Overall Study Modified Intent-to-treat(mITT)Population	372	380	111
Overall Study Per-protocol (PP) Population	345	354	103
Overall Study COMPLETED	356	356	27
Overall Study NOT COMPLETED	43	44	85

Reasons for withdrawal

Reasons for withdrawal
Measure	Generic Ivermectin Lotion 0.5% Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Sklice (Ivermectin) Lotion Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Vehicle Lotion Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
Overall Study Need alternate therapy due to live lice	17	25	81
Overall Study Lost to Follow-up	11	11	3
Overall Study Protocol Violation	0	1	1
Overall Study Withdrawal by Subject	10	4	0
Overall Study Other than specified	5	3	0

Baseline Characteristics

Clinical Endpoint Study of Ivermectin 0.5% Lotion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Generic Ivermectin Lotion 0.5% n=399 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Sklice (Ivermectin) Lotion n=400 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Vehicle Lotion n=112 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Total n=911 Participants Total of all reporting groups
Age, Continuous	18.8 years STANDARD_DEVIATION 15.4 • n=5 Participants	16.8 years STANDARD_DEVIATION 13.9 • n=7 Participants	19.0 years STANDARD_DEVIATION 14.4 • n=5 Participants	18.2 years STANDARD_DEVIATION 14.6 • n=4 Participants
Sex: Female, Male Female	322 Participants n=5 Participants	324 Participants n=7 Participants	97 Participants n=5 Participants	743 Participants n=4 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	76 Participants n=7 Participants	15 Participants n=5 Participants	168 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	344 Participants n=5 Participants	346 Participants n=7 Participants	93 Participants n=5 Participants	783 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	54 Participants n=7 Participants	19 Participants n=5 Participants	128 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	12 Participants n=7 Participants	3 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	377 Participants n=5 Participants	377 Participants n=7 Participants	106 Participants n=5 Participants	860 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Race (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
Number of live lice	4.9 live lice STANDARD_DEVIATION 4.4 • n=5 Participants	4.4 live lice STANDARD_DEVIATION 3.5 • n=7 Participants	4.5 live lice STANDARD_DEVIATION 3.1 • n=5 Participants	4.6 live lice STANDARD_DEVIATION 3.7 • n=4 Participants

PRIMARY outcome

Timeframe: Day 15 ± 2

Population: Index participants in PP population. PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit ( Day 15 ± 2), and had no significant protocol deviations.

Outcome measures

Outcome measures
Measure	Generic Ivermectin Lotion 0.5% n=143 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Sklice (Ivermectin) Lotion n=145 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Vehicle Lotion Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
Percentage of Index Participants Who Were Considered a Treatment Success: PP Population	90.9 percentage of participants	89.0 percentage of participants	—

PRIMARY outcome

Timeframe: Day 15 ± 2

Population: Index participants in mITT population. mITT population included all randomized participants who met all inclusion/exclusion criteria, applied the study product as instructed, and returned for at least 1 post-baseline evaluation visit.

Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.

Outcome measures

Outcome measures
Measure	Generic Ivermectin Lotion 0.5% n=157 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Sklice (Ivermectin) Lotion n=156 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Vehicle Lotion n=49 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population	91.7 percentage of participants	89.7 percentage of participants	28.6 percentage of participants

SECONDARY outcome

Timeframe: Day 15 ± 2

Population: PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit (Day 15 ± 2), and had no significant protocol deviations.

Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice \[ivermectin\] lotion 0.5%) was done in this endpoint, hence placebo group was not included.

Outcome measures

Outcome measures
Measure	Generic Ivermectin Lotion 0.5% n=345 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Sklice (Ivermectin) Lotion n=354 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Vehicle Lotion Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population	91.6 percentage of participants	90.7 percentage of participants	—

SECONDARY outcome

Timeframe: Day 15 ± 2

Population: mITT population included all randomized participants who met all inclusion/exclusion criteria, applied the study product as instructed, and returned for at least one post-baseline evaluation visit.

Outcome measures

Outcome measures
Measure	Generic Ivermectin Lotion 0.5% n=372 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Sklice (Ivermectin) Lotion n=380 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Vehicle Lotion n=111 Participants Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: mITT Population	92.2 percentage of participants	91.3 percentage of participants	25.2 percentage of participants

Adverse Events

Generic Ivermectin Lotion 0.5%

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Vehicle Lotion

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Sklice (Ivermectin) Lotion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director, CE Studies

Teva Pharmaceuticals Inc. USA

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Publication restrictions are in place

Restriction type: OTHER

Measure	Generic Ivermectin Lotion 0.5% n=399 participants at risk Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Vehicle Lotion n=400 participants at risk Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.	Sklice (Ivermectin) Lotion n=112 participants at risk Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
Eye disorders Eye irritation	0.50% 2/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.50% 2/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Eye disorders Ocular discomfort	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Gastrointestinal disorders Abdominal pain upper	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Gastrointestinal disorders Nausea	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Gastrointestinal disorders Vomiting	0.50% 2/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Application site dysaesthesia	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.50% 2/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Application site erythema	0.00% 0/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Application site exfoliation	0.00% 0/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Application site hypoaesthesia	0.00% 0/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Application site laceration	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Application site pain	0.00% 0/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Application site paraesthesia	0.00% 0/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Application site pruritus	2.3% 9/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	2.0% 8/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.89% 1/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
General disorders Influenza like illness	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Infections and infestations Bacterial infection	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Infections and infestations Ear infection	0.00% 0/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Infections and infestations Influenza	0.00% 0/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Infections and infestations Upper respiratory tract infection	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Infections and infestations Urinary tract infection	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Infections and infestations Viral upper respiratory tract infection	0.50% 2/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.50% 2/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Nervous system disorders Headache	2.0% 8/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.50% 2/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Respiratory, thoracic and mediastinal disorders Cough	0.50% 2/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Skin and subcutaneous tissue disorders Rash	0.00% 0/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.25% 1/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).
Vascular disorders Hypertension	0.25% 1/399 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/400 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).	0.00% 0/112 • Baseline up to Day 17 Adverse events were collected from participants who were randomized and received the study drug (Safety population).