Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767271
• Other study ID #: V01-LUZA-401
• Status: Completed
• Phase: Phase 4
• Start date: December 2, 2015
• Est. completion date: April 27, 2016

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 27, 2016
• Est. primary completion date: April 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinea
• Tinea Cruris
• Tinea Pedis

Intervention

Drug:
• Luliconazole Cream 1%
Luliconazole cream will be applied topically per schedule specified in the arms.

Locations

Country	Name	City	State
Dominican Republic	Valeant Site 01	Santo Domingo
Honduras	Valeant Site 02	San Pedro Sula

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

Dominican Republic,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole	Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method.	Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
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	Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.	Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Primary	Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole	Plasma concentration of luliconazole was determined using validated LC/MS method.	Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Primary	Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole	Plasma concentration of luliconazole was determined using validated LC/MS method.	Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Primary	Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole	Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.	Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Primary	Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole	Plasma concentration of luliconazole was determined using validated LC/MS method.	Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8