Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis

Tinea Corporis Clinical Trial

Official title:

A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767947
• Other study ID #: V01-LUZB-401
• Status: Completed
• Phase: Phase 4
• Start date: February 8, 2016
• Est. completion date: September 22, 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 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.

Other known NCT identifiers

• NCT02491112

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 22, 2016
• Est. primary completion date: June 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinea
• Tinea Corporis

Intervention

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

Locations

Country	Name	City	State
Dominican Republic	Valeant Site 03	San Cristobal
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	Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)	Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).	Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7
Primary	Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)	Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7).	6 hours after the final dose of the drug on Day 7