At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
Luliconazole Cream 1%drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study to Assess the Pharmacokinetics With Maximal Use of Luliconazole Cream 1% in Pediatric Patients With Moderate to Severe Tinea Pedis or Tinea Cruris
In Brief
A Phase 4 clinical trial evaluating Luliconazole Cream 1% for Tinea Pedis and Tinea Cruris. Completed, enrolled 30 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinea Pedis, Tinea Cruris
CountriesDominican Republic, Honduras
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
Primary CompletionApr 2016
First PostedMay 2016
TodayJul 2026
First PostedMay 10, 2016
Enrollment StartDec 2, 2015
Primary CompletionApr 27, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.1 years ago
Interventions
Luliconazole Cream 1%drug
Luliconazole cream will be applied topically per schedule specified in the arms.