Back to results

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

Primary Purpose

Tinea Corporis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Luliconazole Cream 1%

Vehicle Cream

About this trial

This is an interventional treatment trial for Tinea Corporis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Valeant Site 03
Valeant Site 01
Valeant Site 02

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Luliconazole Cream 1%

Vehicle Cream

Arm Description

Luliconazole cream 1% will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.

Vehicle cream (containing no active ingredient) will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02767947

First Posted

May 6, 2016

Last Updated

November 8, 2019

Sponsor

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02767947

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

February 8, 2016 (Actual)

Primary Completion Date

June 29, 2016 (Actual)

Study Completion Date

September 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinea Corporis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Luliconazole Cream 1%

Arm Type

Experimental

Arm Description

Luliconazole cream 1% will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.

Arm Title

Vehicle Cream

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Luliconazole Cream 1%

Other Intervention Name(s)

Product 33525

Intervention Description

Luliconazole cream will be applied per schedule specified in the arm.

Intervention Type

Drug

Intervention Name(s)

Vehicle Cream

Intervention Description

Vehicle cream will be applied per schedule specified in the arm.

Primary Outcome Measure Information:

Title

Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)

Description

Time Frame

Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7

Title

Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)

Description

Time Frame

6 hours after the final dose of the drug on Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anya Loncaric

Organizational Affiliation

Valeant Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Valeant Site 03

City

San Cristobal

ZIP/Postal Code

91000

Country

Dominican Republic

Facility Name

Valeant Site 01

City

Santo Domingo

ZIP/Postal Code

10700

Country

Dominican Republic

Facility Name

Valeant Site 02

City

San Pedro Sula

ZIP/Postal Code

CT1100

Country

Honduras

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs