Tinea Corporis
Conditions
Brief summary
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.
Interventions
Luliconazole cream will be applied per schedule specified in the arm.
DRUGVehicle Cream
Vehicle cream will be applied per schedule specified in the arm.
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants (or legal guardian/caregiver) with the ability and willingness to sign a written informed consent and/or assent (age appropriate). * Participants of either gender must be at least 2 years to less than (\<) 18 years of age (2 to 17 years, inclusive). * Participants with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate pruritus). * 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/caregiver 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 active atopic or contact dermatitis in the area to be treated. * Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection. * 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 study drug will be discontinued from study drug 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 |
|---|---|---|
| Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) | Pre-dose (within 15 minutes prior to the final dose of the drug) 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). |
| Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) | 6 hours after the final dose of the drug 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). |
Countries
Dominican Republic, Honduras
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 15 |
| Total | 75 |
Baseline characteristics
| Characteristic | Luliconazole Cream 1% | Vehicle Cream | Total |
|---|---|---|---|
| Age, Continuous | 8.18 years STANDARD_DEVIATION 3.87 | 9.13 years STANDARD_DEVIATION 5.18 | 8.37 years STANDARD_DEVIATION 4.14 |
| Sex: Female, Male Female | 18 Participants | 3 Participants | 21 Participants |
| Sex: Female, Male Male | 42 Participants | 12 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 60 | 2 / 15 |
| serious Total, serious adverse events | 0 / 60 | 0 / 15 |
Outcome results
Primary
Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)
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).
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Luliconazole Cream 1% | Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) | 4.84 ng/mL | Standard Deviation 3.33 |
| Vehicle Cream | Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) | 0.07 ng/mL | Standard Deviation 0.12 |
Primary
Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)
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).
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Luliconazole Cream 1% | Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) | 4.63 nanograms/milliliter (ng/mL) | Standard Deviation 2.93 |
| Vehicle Cream | Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) | NA nanograms/milliliter (ng/mL) | — |