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

NCT02767947 | Completed Phase 4 Results

• 1 other identifier: V01-LUZB-401
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 3

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.

Conditions

Tinea Corporis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Luliconazole Cream 1%

EXPERIMENTAL

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.

Drug: Luliconazole Cream 1%

Vehicle Cream

PLACEBO COMPARATOR

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.

Drug: Vehicle Cream

Interventions

Luliconazole Cream 1% DRUG

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

Also known as: Product 33525

Luliconazole Cream 1%

Vehicle Cream DRUG

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

Vehicle Cream

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (3)

Valeant Site 03

San Cristóbal, 91000, Dominican Republic

Location

Valeant Site 01

Santo Domingo, 10700, Dominican Republic

Location

Valeant Site 02

San Pedro Sula, CT1100, Honduras

Location

MeSH Terms

Conditions

Tinea

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc

aloncaric@bauschhealth.com

Study Officials

• Anya Loncaric

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: February 8, 2016
• Primary Completion: June 29, 2016
• Study Completion: September 22, 2016
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DO (2); HO (1)