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

• Status: Completed
• Trial end date: 2016-09-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Luliconazole

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.