Tinea Pedis, Tinea Cruris
Conditions
Brief 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.
Interventions
Luliconazole cream will be applied topically per schedule specified in the arms.
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method. |
| 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 | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 | Plasma concentration of luliconazole was determined using validated LC/MS method. |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | Plasma concentration of luliconazole was determined using validated LC/MS method. |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 | Plasma concentration of luliconazole was determined using validated LC/MS method. |
Countries
Dominican Republic, Honduras
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Tinea Pedis | Tinea Cruris | Total |
|---|---|---|---|
| Age, Continuous | 14.13 years STANDARD_DEVIATION 2.17 | 15.27 years STANDARD_DEVIATION 1.49 | 14.70 years STANDARD_DEVIATION 1.91 |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tinea Pedis | 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
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tinea Pedis | 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
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tinea Pedis | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole | 49.77 hours | Standard Deviation 22.74 |
Primary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 Luliconazole | 60.38 nanograms*hour/milliliter (ng*hr/mL) | Standard Deviation 37.92 |
Primary
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
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.
Primary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tinea Pedis | 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 |