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

Bausch Health

Status and phase: Completed; Phase 4

Conditions: Tinea Corporis

Treatments: Drug: Luliconazole Cream 1%; Drug: Vehicle Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT02767947

V01-LUZB-401

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

75 participants in 2 patient groups, including a placebo group

Luliconazole Cream 1%

Experimental group

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.

Treatment:

Drug: Luliconazole Cream 1%

Vehicle Cream

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vehicle Cream