Trial Outcomes & Findings for Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis) (NCT NCT04432376)

NCT ID: NCT04432376

Last Updated: 2024-01-19

Results Overview

"therapeutic cure" is "mycological cure" plus "clinical cure, in the Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Fungal culture results verified as (+) or (-) after enrollment. Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). Mycological cure is a negative mycological culture (culture is either positive or negative). Score=0 is best. Clinical cure is absence of all otomycosis signs and symptoms (s/s) of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best. Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 382 participants
• Primary outcome timeframe: 21 days from first day of drug application
• Results posted on: 2024-01-19

Participant Flow

Participant milestones

Measure	Active Treatment Arm Participants randomized to Active Treatment with miconazole 2% oil, 5 drops into affected ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Placebo Treatment Arm Participants randomized to Placebo Treatment (with vehicle oil placebo), 5 drops into affected ear twice daily for 14 consecutive days vehicle oil: Placebo treatment of otomycosis for 14 days	Open-label Application Group Application of miconazole 2% oil, 5 drops into each ear or the affected ear, twice daily for 14 consecutive days miconazole 2% oil: Drug application for 14 days
Double-blind Treatment Period STARTED	89	90	0
Double-blind Treatment Period COMPLETED	84	79	0
Double-blind Treatment Period NOT COMPLETED	5	11	0
Enrollment B, Open Label Safety Group. STARTED	0	0	203
Enrollment B, Open Label Safety Group. COMPLETED	0	0	203
Enrollment B, Open Label Safety Group. NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	Active Treatment Arm Participants randomized to Active Treatment with miconazole 2% oil, 5 drops into affected ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Placebo Treatment Arm Participants randomized to Placebo Treatment (with vehicle oil placebo), 5 drops into affected ear twice daily for 14 consecutive days vehicle oil: Placebo treatment of otomycosis for 14 days	Open-label Application Group Application of miconazole 2% oil, 5 drops into each ear or the affected ear, twice daily for 14 consecutive days miconazole 2% oil: Drug application for 14 days
Double-blind Treatment Period Adverse Event	2	6	0
Double-blind Treatment Period Lost to Follow-up	2	1	0
Double-blind Treatment Period Withdrawal by Subject	1	2	0
Double-blind Treatment Period Protocol Violation	0	1	0
Double-blind Treatment Period subject enrolled in the Optional Open Label arm	0	1	0

Baseline Characteristics

Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)

Baseline characteristics by cohort

Measure	Active Treatment Arm n=89 Participants Treatment with miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Placebo Treatment Arm n=90 Participants Treatment with the vehicle oil, placebo, 5 drops into each ear twice daily for 14 consecutive days vehicle oil: Placebo treatment of otomycosis for 14 days	Open-label Treatment Arm n=203 Participants Application of miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Total n=382 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	17 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	61 Participants n=7 Participants	178 Participants n=5 Participants	295 Participants n=4 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	23 Participants n=7 Participants	15 Participants n=5 Participants	70 Participants n=4 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	44 Participants n=7 Participants	142 Participants n=5 Participants	224 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	46 Participants n=7 Participants	61 Participants n=5 Participants	158 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants	80 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	71 Participants n=7 Participants	165 Participants n=5 Participants	302 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	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	12 Participants n=7 Participants	49 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) White	76 Participants n=5 Participants	68 Participants n=7 Participants	133 Participants n=5 Participants	277 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants	22 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
Mycological culture positive culture	67 Participants n=5 Participants	64 Participants n=7 Participants	0 Participants n=5 Participants	131 Participants n=4 Participants
Mycological culture negative culture	22 Participants n=5 Participants	26 Participants n=7 Participants	0 Participants n=5 Participants	48 Participants n=4 Participants
Mycological culture not cultured	0 Participants n=5 Participants	0 Participants n=7 Participants	203 Participants n=5 Participants	203 Participants n=4 Participants
Otomycosis signs/symptoms - Pruritus none	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Otomycosis signs/symptoms - Pruritus mild	18 Participants n=5 Participants	19 Participants n=7 Participants	0 Participants n=5 Participants	37 Participants n=4 Participants
Otomycosis signs/symptoms - Pruritus moderate	58 Participants n=5 Participants	56 Participants n=7 Participants	0 Participants n=5 Participants	114 Participants n=4 Participants
Otomycosis signs/symptoms - Pruritus severe	12 Participants n=5 Participants	13 Participants n=7 Participants	0 Participants n=5 Participants	25 Participants n=4 Participants
Otomycosis signs/symptoms - Pruritus not assessed	0 Participants n=5 Participants	0 Participants n=7 Participants	203 Participants n=5 Participants	203 Participants n=4 Participants
Otomycosis signs/symptoms - Debris none	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Otomycosis signs/symptoms - Debris scant	6 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Otomycosis signs/symptoms - Debris moderate	44 Participants n=5 Participants	59 Participants n=7 Participants	0 Participants n=5 Participants	103 Participants n=4 Participants
Otomycosis signs/symptoms - Debris heavy	39 Participants n=5 Participants	29 Participants n=7 Participants	0 Participants n=5 Participants	68 Participants n=4 Participants
Otomycosis signs/symptoms - Debris not assessed	0 Participants n=5 Participants	0 Participants n=7 Participants	203 Participants n=5 Participants	203 Participants n=4 Participants
Otomycosis signs/symptoms - Fungal elements present	89 Participants n=5 Participants	90 Participants n=7 Participants	0 Participants n=5 Participants	179 Participants n=4 Participants
Otomycosis signs/symptoms - Fungal elements absent	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Otomycosis signs/symptoms - Fungal elements not assessed	0 Participants n=5 Participants	0 Participants n=7 Participants	203 Participants n=5 Participants	203 Participants n=4 Participants
Otomycosis signs/symptoms - Aural fullness none	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Otomycosis signs/symptoms - Aural fullness mild	27 Participants n=5 Participants	31 Participants n=7 Participants	0 Participants n=5 Participants	58 Participants n=4 Participants
Otomycosis signs/symptoms - Aural fullness moderate	55 Participants n=5 Participants	44 Participants n=7 Participants	0 Participants n=5 Participants	99 Participants n=4 Participants
Otomycosis signs/symptoms - Aural fullness severe	7 Participants n=5 Participants	14 Participants n=7 Participants	0 Participants n=5 Participants	21 Participants n=4 Participants
Otomycosis signs/symptoms - Aural fullness not assessed	0 Participants n=5 Participants	0 Participants n=7 Participants	203 Participants n=5 Participants	203 Participants n=4 Participants

PRIMARY outcome

Timeframe: 21 days from first day of drug application

Population: MITT (modified intent-to-treat) population - only patients with positive mycological culture at Baseline. ITT (intent-to-treat) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).

"therapeutic cure" is "mycological cure" plus "clinical cure, in the Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Fungal culture results verified as (+) or (-) after enrollment.

Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).

Mycological cure is a negative mycological culture (culture is either positive or negative). Score=0 is best.

Clinical cure is absence of all otomycosis signs and symptoms (s/s) of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best.

Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline.

Outcome measures

Measure	Active Treatment Arm n=67 Participants Treatment with miconazole 2% oil, 5 drops into affected ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Placebo Treatment Arm n=64 Participants Treatment with the vehicle oil, placebo, 5 drops into affected ear twice daily for 14 consecutive days vehicle oil: Placebo treatment of otomycosis for 14 days
Percentage of Subjects With Therapeutic Cure Achieved Therapeutic cure (Score=0 fungal culture and clinical signs,symptoms)	14 Participants	11 Participants
Percentage of Subjects With Therapeutic Cure Not Achieve Therapeutic cure (Positive fungal culture AND/OR clinical score 1 or greater each s/s	53 Participants	53 Participants

SECONDARY outcome

Timeframe: 21 days from first day of drug application

Population: MITT (modified intent-to-treat) population - only patients with positive mycological culture at Baseline. ITT population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).

Mycological cure is a negative mycological culture for the study ear at test of cure visit, in Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Subjects that had negative fungal culture at Baseline were not included in MITT. Fungal culture results verified as (+) or (-) after enrollment.

Grading is based on positive or negative mycological (fungal) culture. Negative culture is required.

Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline.

Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).

Outcome measures

Measure	Active Treatment Arm n=67 Participants Treatment with miconazole 2% oil, 5 drops into affected ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Placebo Treatment Arm n=64 Participants Treatment with the vehicle oil, placebo, 5 drops into affected ear twice daily for 14 consecutive days vehicle oil: Placebo treatment of otomycosis for 14 days
Percentage of Subjects With Mycological Cure Not achieved mycological cure (positive fungal culture)	43 Participants	49 Participants
Percentage of Subjects With Mycological Cure Achieved mycological cure (negative fungal culture)	24 Participants	15 Participants

SECONDARY outcome

Timeframe: 21 days from first day of drug application

Population: MITT (modified intent-to-treat) population - only patients with positive mycological culture at Baseline. ITT population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).

Absence of all otomycosis signs and symptoms according to the scales for each individual sign/symptom. Score=0 is best.

Clinical cure is absence of all otomycosis signs and symptoms of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best.

Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline. Subjects that had negative fungal culture at Baseline were not included in MITT. Fungal culture results verified as (+) or (-) after enrollment.

ITT (intent to treat) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).

Outcome measures

Measure	Active Treatment Arm n=67 Participants Treatment with miconazole 2% oil, 5 drops into affected ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Placebo Treatment Arm n=64 Participants Treatment with the vehicle oil, placebo, 5 drops into affected ear twice daily for 14 consecutive days vehicle oil: Placebo treatment of otomycosis for 14 days
Percentage of Subjects With Clinical Cure Achieved clinical cure (score = 0 for all signs, symptoms)	22 Participants	14 Participants
Percentage of Subjects With Clinical Cure Not achieved clinical cure (score equal to or greater than 1 for each sign, symptom).	45 Participants	50 Participants

Adverse Events

Active Treatment Arm

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo Treatment Arm

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Open-label Treatment Arm

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Treatment Arm n=89 participants at risk Treatment with miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Placebo Treatment Arm n=90 participants at risk Treatment with the vehicle oil, placebo, 5 drops into each ear twice daily for 14 consecutive days vehicle oil: Placebo treatment of otomycosis for 14 days	Open-label Treatment Arm n=203 participants at risk Application of miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days
Renal and urinary disorders acute kidney injury	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Vascular disorders hypotension	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.

Other adverse events

Measure	Active Treatment Arm n=89 participants at risk Treatment with miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days	Placebo Treatment Arm n=90 participants at risk Treatment with the vehicle oil, placebo, 5 drops into each ear twice daily for 14 consecutive days vehicle oil: Placebo treatment of otomycosis for 14 days	Open-label Treatment Arm n=203 participants at risk Application of miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days miconazole 2% oil: Drug treatment of otomycosis for 14 days
Ear and labyrinth disorders ear discomfort	9.0% 8/89 • Number of events 8 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	10.0% 9/90 • Number of events 9 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Ear and labyrinth disorders vertigo	2.2% 2/89 • Number of events 2 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.49% 1/203 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Ear and labyrinth disorders tinnitus	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Ear and labyrinth disorders tympanic membrane perforation	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Infections and infestations ear infection fungal	30.3% 27/89 • Number of events 27 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	36.7% 33/90 • Number of events 33 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Infections and infestations otitis externa	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.99% 2/203 • Number of events 2 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Infections and infestations gastroenteritis viral	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Infections and infestations otitis externa bacterial	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Infections and infestations otitis externa fungal	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Infections and infestations COVID-19	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Infections and infestations tooth abscess	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Gastrointestinal disorders diarrhea	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Gastrointestinal disorders dry mouth	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
General disorders application site irritation	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.49% 1/203 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
General disorders application site pain	4.5% 4/89 • Number of events 4 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	3.3% 3/90 • Number of events 3 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
General disorders application site pruritus	7.9% 7/89 • Number of events 7 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	8.9% 8/90 • Number of events 8 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.5% 3/203 • Number of events 3 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Injury, poisoning and procedural complications exposure to SARS-CoV-2	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Metabolism and nutrition disorders hyponatremia	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Metabolism and nutrition disorders hypovolemia	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Musculoskeletal and connective tissue disorders arthritis	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Nervous system disorders headache	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.99% 2/203 • Number of events 2 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Respiratory, thoracic and mediastinal disorders paranasal cyst	0.00% 0/89 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.
Respiratory, thoracic and mediastinal disorders rhinitis allergic	1.1% 1/89 • Number of events 1 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/90 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.	0.00% 0/203 • Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion. Treatment-emergent adverse events (TEAEs) are those with an onset on or after the date of first study drug application, up to the last application day for each patient. Adverse events were monitored through study completion.

Additional Information

Dr. Rosario G Ramirez, Medical Director

Hill Dermaceuticals

Phone: 4073231887

Email: nini.ramirez@hillderm.com

Results disclosure agreements

• Principal investigator is a sponsor employee Proprietary Information will need prior written consent of the sponsor. PI will hold in confidence and not disclose any Proprietary Information unless disclosure has its prior written consent from sponsor, or that the information is disclosed to personnel who need to know. Sponsor will not prohibit PI to comply with applicable laws and regulations, provided PI gives prior written notice to Sponsor. Disclosure allowed if legally required and accorded confidential treatment.
• Publication restrictions are in place

Restriction type: OTHER