Overview

This trial is active, not recruiting.

Conditions tinea pedis, tinea cruris
Treatment luliconazole cream 1%
Phase phase 4
Sponsor Valeant Pharmaceuticals International, Inc.
Start date December 2015
End date April 2016
Trial size 30 participants
Trial identifier NCT02767271, V01-LUZA-401

Summary

The objective of this study is to evaluate the pharmacokinetics of Luliconazole Cream 1% in subjects with moderate to severe tinea pedis or tinea cruris.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Luliconazole Cream 1%
luliconazole cream 1% Luliconazole
Luliconazole

Primary Outcomes

Measure
Measurement of circulating plasma levels of Luliconazole in subjects who have tinea pedis.
time frame: 15 days
Measurement of circulating plasma levels of Luliconazole in subjects who have tinea cruris
time frame: 8 days

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

Key Inclusion Criteria: - Subjects (or legal guardian) with the ability and willingness to sign a written informed consent - Subjects of either gender at least 12 years to <18 years old (12 to 17 years, inclusive) - Subjects with a mycological diagnosis of tinea pedis or tinea cruris confirmed by the detection of fungal hyphae on a microscopic KOH wet mount - Subjects with the ability and willingness to follow all study procedures, attend all scheduled visits, have all blood draws, and successfully complete the study - Subjects must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations. - Subjects must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements. Key Exclusion Criteria: - Subjects with both tinea pedis and tinea cruris. - Subjects with active atopic or contact dermatitis in the treatment area. - Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Subjects who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes. - Subjects who are immunocompromised (due to disease, e.g., HIV or medications). - Subjects who have a recent history of or current drug or alcohol abuse.

Additional Information

Official title 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
Description 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 patients 12 years to < 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Valeant Pharmaceuticals International, Inc..