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CompletedNCT02767271Updated Nov 27, 2019Results posted

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

A Phase 4 interventional study of Luliconazole Cream 1% in Tinea Pedis and Tinea Cruris, sponsored by Bausch Health Americas, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-11-27.

Sponsored by Bausch Health Americas, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole cream 1% is applied to participants of 12 years to less than (\<) 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.

02

Conditions studied

  • Tinea Pedis
  • Tinea Cruris

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03

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Participants (or legal guardian) with the ability and willingness to sign a written informed consent.
  • Participants of either gender at least 12 years to \<18 years old (12 to 17 years, inclusive).
  • Participants with a mycological diagnosis of tinea pedis or tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount.
  • Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, have all blood draws, and successfully complete the study.
  • Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
  • Participants must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.

Key Exclusion Criteria:

  • Participants with both tinea pedis and tinea cruris.
  • Participants with active atopic or contact dermatitis in the treatment area.
  • Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes.
  • Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus [HIV] or medications).
  • Participants who have a recent history of or current drug or alcohol abuse.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    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, including up to the ankles.

    Drug: Luliconazole Cream 1%

  • Experimental
    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, including up to the groin, thighs, and abdomen.

    Drug: Luliconazole Cream 1%

Interventions

  • DrugLuliconazole Cream 1%

    Luliconazole cream will be applied topically per schedule specified in the arms.

05

What researchers measure

Primary outcomes

  1. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole

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

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

  2. 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

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

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

  3. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole

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

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

  4. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole

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

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

  5. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole

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

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

  6. Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole

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

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

06

Results

Posted Nov 27, 2019

Participant flow

Participant flow — Overall Study
MilestoneTinea PedisTinea Cruris
Started1515
Safety population1515
Pharmacokinetic pedis (pkp) population150
Pharmacokinetic cruris (pkc) population015
Completed1515
Not completed00

Outcome measures

PrimaryMeasurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole

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

Time frame:
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Reported as:
Mean · nanograms/milliliter (ng/mL)
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole
nanograms/milliliter (ng/mL)Tinea Pedis
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole3.27 ± 1.71
PrimaryMeasurement 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

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

Time frame:
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Reported as:
Mean · nanograms*hour/milliliter (ng*hr/mL)
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
nanograms*hour/milliliter (ng*hr/mL)Tinea Pedis
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 Luliconazole60.38 ± 37.92
PrimaryMeasurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole

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

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

No measurements were reported for this outcome.

PrimaryMeasurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole

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

Time frame:
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Reported as:
Mean · ng/mL
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole
ng/mLTinea Cruris
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole15.40 ± 13.62
PrimaryMeasurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole

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

Time frame:
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Reported as:
Mean · ng*hr/mL
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole
ng*hr/mLTinea Cruris
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole266.06 ± 236.07
PrimaryMeasurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole

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

Time frame:
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Reported as:
Mean · hours
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole
hoursTinea Cruris
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole49.77 ± 22.74

Adverse events

Collected over Baseline (Day 1) up to Day 16. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tinea Pedis—0/15 (0%)2/15 (13.3%)
Tinea Cruris—0/15 (0%)1/15 (6.7%)
Most frequent other events
Most frequent other events
EventTinea PedisTinea Cruris
DiarrheaGastrointestinal disorders1/150/15
NasopharyngitisInfections and infestations0/151/15
HeadacheNervous system disorders1/150/15

Baseline characteristics

Safety population included all participants who were enrolled and received at least 1 application of study drug.

Age, Continuous
Age, Continuous(years)Tinea PedisTinea CrurisTotal
Mean14.13 ± 2.1715.27 ± 1.4914.70 ± 1.91
Sex: Female, Male
Sex: Female, Male(Participants)Tinea PedisTinea CrurisTotal
Female257
Male131023
07

Study locations

2 sites
  • Valeant Site 01
    Santo Domingo, 10700, Dominican Republic
  • Valeant Site 02
    San Pedro Sula, CT1100, Honduras
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Registry details

Key details

Study ID
NCT02767271
Lead sponsor
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
May 10, 2016
Start date
Dec 2, 2015
Primary completion
Apr 27, 2016
Completion
Apr 27, 2016
Results posted
Nov 27, 2019
Last update
Nov 27, 2019

Study contacts

Anya Loncaric
study director · Valeant Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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