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OpenTrials
Completed

NCT Number: NCT02767947

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

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Valeant Site 03, San Cristobal, Dominican Republic

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Luliconazole Cream 1%

Drug

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

Other names: Product 33525

Vehicle cream

Drug

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

Primary outcomes

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

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

    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).

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

    Time frame: 6 hours after the final dose of the drug on Day 7

    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).

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 11, 2016
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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