Trial Outcomes & Findings for Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis (NCT NCT03130738)

Last Updated: 2022-10-05

Results Overview

Percentage of subjects in MITT population, at the "Test of Cure" visit with "Therapeutic cure", defined as a negative fungal culture plus "clinical cure" defined as the absence of all otomycosis signs and symptoms for pruritus, debris, fungal elements, and pain.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)

Results posted on

2022-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	7-Day Miconazole Oil (Miconazole 2%) 7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Miconazole Oil (Miconazole 2%) 14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Placebo - Oil Vehicle 14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient 14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
Overall Study STARTED	23	22	20
Overall Study COMPLETED	20	20	14
Overall Study NOT COMPLETED	3	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	7-Day Miconazole Oil (Miconazole 2%) n=23 Participants 7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Miconazole Oil (Miconazole 2%) n=22 Participants 14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Placebo - Oil Vehicle n=20 Participants 14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient 14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient	Total n=65 Participants Total of all reporting groups
Age, Continuous	64.0 years n=5 Participants	66.0 years n=7 Participants	62.5 years n=5 Participants	64 years n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	33 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	60 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	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 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	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	55 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 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
Region of Enrollment United States	23 Participants n=5 Participants	22 Participants n=7 Participants	20 Participants n=5 Participants	65 Participants n=4 Participants
Mycological culture Positive mycological culture	12 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	38 Participants n=4 Participants
Mycological culture Negative mycological culture	11 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	27 Participants n=4 Participants
Pruritus - investigator assessed Mild, moderate or severe	10 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	35 Participants n=4 Participants
Pruritus - investigator assessed None	13 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	30 Participants n=4 Participants
Debris Scant, moderate or Heavy	12 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	38 Participants n=4 Participants
Debris None	11 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	27 Participants n=4 Participants
Presence of fungal elements Present	12 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	38 Participants n=4 Participants
Presence of fungal elements Absent	11 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	27 Participants n=4 Participants
Pain Present	9 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	30 Participants n=4 Participants
Pain Absent	14 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	35 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)

Population: Actual number of participants analyzed under Primary efficacy endpoint are MITT population, defined as subjects who had a clinical diagnosis of otomycosis confirmed by positive fungal culture.

Outcome measures

Outcome measures
Measure	7-Day Miconazole Oil (Miconazole 2%) n=12 Participants 7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Miconazole Oil (Miconazole 2%) n=12 Participants 14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Placebo - Oil Vehicle n=14 Participants 14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient 14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
Primary Efficacy Endpoint	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)

Population: Percentage of subjects in the MITT population.

1. Percentage of subjects in MITT population with clinical cure at the Test of Cure Visit 2. Percentage of subjects in MITT population with a negative fungal culture at the Test of Cure Visit 3. Percentage of subjects in MITT population with a negative fungal culture at the Test of Cure visit as well as individual sign or symptom score of 0 or 1 on each of the scales for pruritus and debris and a score of 0 on each of the scales for fungal elements and pain (Secondary therapeutic cure). 4. Percentage of subjects in MITT population with individual signs or symptoms with a score of 0 or 1 on each of the scales for pruritus and debris and a score of 0 on each of the scales for fungal elements and pain (Secondary clinical cure).

Outcome measures

Outcome measures
Measure	7-Day Miconazole Oil (Miconazole 2%) n=12 Participants 7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Miconazole Oil (Miconazole 2%) n=12 Participants 14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Placebo - Oil Vehicle n=14 Participants 14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient 14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
Secondary Efficacy Endpoints Clinical Cure	2 Participants	4 Participants	2 Participants
Secondary Efficacy Endpoints Negative Fungal Culture	4 Participants	5 Participants	3 Participants
Secondary Efficacy Endpoints Secondary Therapeutic Cure	3 Participants	5 Participants	1 Participants
Secondary Efficacy Endpoints Secondary Clinical Cure	7 Participants	6 Participants	4 Participants

Adverse Events

7-Day Miconazole Oil (Miconazole 2%)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

14-Day Miconazole Oil (Miconazole 2%)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

14-Day Placebo - Oil Vehicle

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	7-Day Miconazole Oil (Miconazole 2%) n=23 participants at risk 7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 7-Day Miconazole Oil (Miconazole 2%): 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Miconazole Oil (Miconazole 2%) n=22 participants at risk 14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) 14-Day Miconazole Oil (Miconazole 2%): 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)	14-Day Placebo - Oil Vehicle n=20 participants at risk 14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient 14-Day Placebo - Oil Vehicle: 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
Ear and labyrinth disorders Ear pain. Tympanic membrane perforation	0.00% 0/23 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	0.00% 0/22 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	20.0% 4/20 • Number of events 4 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
Gastrointestinal disorders nausea	0.00% 0/23 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	0.00% 0/22 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	5.0% 1/20 • Number of events 1 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
General disorders discharge. discomfort. erosion. pain. pruritus. site pain	17.4% 4/23 • Number of events 4 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	27.3% 6/22 • Number of events 8 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	45.0% 9/20 • Number of events 12 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
Immune system disorders Seasonal allergy	0.00% 0/23 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	4.5% 1/22 • Number of events 1 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	0.00% 0/20 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
Infections and infestations site infection. ear fugal infection. myringitis.bacterial otitis externa. otitis media. skin infecti	17.4% 4/23 • Number of events 4 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	13.6% 3/22 • Number of events 4 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	10.0% 2/20 • Number of events 2 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/23 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	4.5% 1/22 • Number of events 1 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	0.00% 0/20 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
Musculoskeletal and connective tissue disorders arthritis. rheumatoid arthritis.	0.00% 0/23 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	4.5% 1/22 • Number of events 1 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	5.0% 1/20 • Number of events 1 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
Nervous system disorders Dysgeusia	0.00% 0/23 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	4.5% 1/22 • Number of events 1 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	0.00% 0/20 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
Respiratory, thoracic and mediastinal disorders rheumatoid lung	0.00% 0/23 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	4.5% 1/22 • Number of events 1 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	0.00% 0/20 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.
Metabolism and nutrition disorders gout	4.3% 1/23 • Number of events 1 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	0.00% 0/22 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.	0.00% 0/20 • The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit. AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.

Additional Information

Rosario G Ramirez, MD

Hill Dermaceuticals, Inc.

Phone: 407-323-1887

Email: [email protected]

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