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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-08

Study Completion Date

2016-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

NCT02767271

Tinea Pedis Tinea Cruris

COMPLETED PHASE4

Topical Antifungal Treatment for Tinea Cruris

NCT01342315

Tinea Cruris

COMPLETED PHASE3

Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)

NCT00869336

Tinea Pedis

COMPLETED PHASE2

Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis

NCT01349998

Tinea Pedis Tinea Cruris Tinea Corporis

COMPLETED PHASE3

Topical Antifungal Treatment for Tinea Pedis

NCT01396785

Tinea Pedis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tinea Corporis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Luliconazole Cream 1%

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.

Group Type EXPERIMENTAL

Luliconazole Cream 1%

Intervention Type DRUG

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

Vehicle Cream

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.

Group Type PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Luliconazole Cream 1%

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

Intervention Type DRUG

Vehicle Cream

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Product 33525

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No