Phase 4
N=75
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
Tinea Corporis
Bottom Line
View on ClinicalTrials.gov: NCT02767947 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) — 4.63; NA nanograms/milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Luliconazole Cream 1% (Drug); Vehicle Cream (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) |
4.63; NA | — |
| PRIMARY Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) |
4.84; 0.07 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02767947). 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.