Phase 4
N=30
Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris
Tinea Pedis · Tinea Cruris
Bottom Line
View on ClinicalTrials.gov: NCT02767271 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: 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)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Luliconazole Cream 1% (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole |
3.27 | — |
| 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 |
60.38 | — |
| PRIMARY Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole |
— | — |
| PRIMARY Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole |
15.40 | — |
| PRIMARY Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole |
266.06 | — |
| PRIMARY Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole |
49.77 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02767271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.