Trial Outcomes & Findings for Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis (NCT NCT02767947)

Results Overview

Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7

Results posted on

2019-11-27

Participant Flow

A total of 75 participants with tinea corporis were enrolled and randomized in 4:1 ratio to receive either luliconazole cream 1% or vehicle cream.

Participant milestones

Participant milestones
Measure	Luliconazole Cream 1% Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.	Vehicle Cream Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Overall Study STARTED	60	15
Overall Study Safety Population	60	15
Overall Study Pharmacokinetic (PK) Population	12	3
Overall Study COMPLETED	60	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Luliconazole Cream 1% n=60 Participants Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.	Vehicle Cream n=15 Participants Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.	Total n=75 Participants Total of all reporting groups
Age, Continuous	8.18 years STANDARD_DEVIATION 3.87 • n=5 Participants	9.13 years STANDARD_DEVIATION 5.18 • n=7 Participants	8.37 years STANDARD_DEVIATION 4.14 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	3 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	12 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7

Population: PK population included all randomized participants who received at least 1 application of study drug, and from whom blood samples were obtained for plasma level analysis both prior to (within 15 minutes) and 6 hours after the final dose (on Day 7).

Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).

Outcome measures

Outcome measures
Measure	Luliconazole Cream 1% n=12 Participants Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.	Vehicle Cream n=3 Participants Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)	4.63 nanograms/milliliter (ng/mL) Standard Deviation 2.93	NA nanograms/milliliter (ng/mL) Standard Deviation NA Data not available due to concentration below the limit of quantitation.

PRIMARY outcome

Timeframe: 6 hours after the final dose of the drug on Day 7

Population: PK population included all randomized participants who received at least 1 application of study drug, and from whom blood samples were obtained for plasma level analysis both prior to (within 15 minutes) and 6 hours after the final dose (on Day 7).

Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7).

Outcome measures

Outcome measures
Measure	Luliconazole Cream 1% n=12 Participants Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.	Vehicle Cream n=3 Participants Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)	4.84 ng/mL Standard Deviation 3.33	0.07 ng/mL Standard Deviation 0.12

Adverse Events

Luliconazole Cream 1%

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Luliconazole Cream 1% n=60 participants at risk Luliconazole cream 1% was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.	Vehicle Cream n=15 participants at risk Vehicle cream (containing no active ingredient) was applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Infections and infestations Nasopharyngitis	6.7% 4/60 • From Baseline (Day 1) to Day 28 Safety population included all randomized participants who received at least 1 application of study drug.	13.3% 2/15 • From Baseline (Day 1) to Day 28 Safety population included all randomized participants who received at least 1 application of study drug.
Nervous system disorders Headache	5.0% 3/60 • From Baseline (Day 1) to Day 28 Safety population included all randomized participants who received at least 1 application of study drug.	0.00% 0/15 • From Baseline (Day 1) to Day 28 Safety population included all randomized participants who received at least 1 application of study drug.

Additional Information

Director of Clinical Operations

Bausch Health Americas, Inc

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
Publication restrictions are in place

Restriction type: OTHER