Trial Outcomes & Findings for Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris (NCT NCT02767271)

Results Overview

Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15

Results posted on

2019-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Tinea Pedis Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.	Tinea Cruris Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
Overall Study STARTED	15	15
Overall Study Safety Population	15	15
Overall Study Pharmacokinetic Pedis (PKP) Population	15	0
Overall Study Pharmacokinetic Cruris (PKC) Population	0	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tinea Pedis n=15 Participants Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.	Tinea Cruris n=15 Participants Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.	Total n=30 Participants Total of all reporting groups
Age, Continuous	14.13 years STANDARD_DEVIATION 2.17 • n=5 Participants	15.27 years STANDARD_DEVIATION 1.49 • n=7 Participants	14.70 years STANDARD_DEVIATION 1.91 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15

Population: PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 pharmacokinetic (PK) assessment.

Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method.

Outcome measures

Outcome measures
Measure	Tinea Pedis n=15 Participants Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole	3.27 nanograms/milliliter (ng/mL) Standard Deviation 1.71

PRIMARY outcome

Timeframe: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15

Population: PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment.

Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.

Outcome measures

Outcome measures
Measure	Tinea Pedis n=15 Participants Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Luliconazole	60.38 nanogramshour/milliliter (nghr/mL) Standard Deviation 37.92

PRIMARY outcome

Timeframe: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15

Population: PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. None of the participants in this population was evaluable for this outcome measure at specified timepoint.

Plasma concentration of luliconazole was determined using validated LC/MS method.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8

Population: PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment.

Plasma concentration of luliconazole was determined using validated LC/MS method.

Outcome measures

Outcome measures
Measure	Tinea Pedis n=15 Participants Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole	15.40 ng/mL Standard Deviation 13.62

PRIMARY outcome

Timeframe: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8

Population: PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment.

Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.

Outcome measures

Outcome measures
Measure	Tinea Pedis n=15 Participants Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole	266.06 ng*hr/mL Standard Deviation 236.07

PRIMARY outcome

Timeframe: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8

Population: PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Plasma concentration of luliconazole was determined using validated LC/MS method.

Outcome measures

Outcome measures
Measure	Tinea Pedis n=3 Participants Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole	49.77 hours Standard Deviation 22.74

Adverse Events

Tinea Pedis

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Tinea Cruris

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tinea Pedis n=15 participants at risk Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.	Tinea Cruris n=15 participants at risk Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Baseline (Day 1) up to Day 16 Safety population included all participants who were enrolled and received at least 1 application of study drug.	0.00% 0/15 • Baseline (Day 1) up to Day 16 Safety population included all participants who were enrolled and received at least 1 application of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/15 • Baseline (Day 1) up to Day 16 Safety population included all participants who were enrolled and received at least 1 application of study drug.	6.7% 1/15 • Baseline (Day 1) up to Day 16 Safety population included all participants who were enrolled and received at least 1 application of study drug.
Nervous system disorders Headache	6.7% 1/15 • Baseline (Day 1) up to Day 16 Safety population included all participants who were enrolled and received at least 1 application of study drug.	0.00% 0/15 • Baseline (Day 1) up to Day 16 Safety population included all participants who were enrolled and 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