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

NCT ID: NCT02767271

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-02
• Study Completion Date: 2016-04-27

Brief Summary

The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole cream 1% is applied to participants of 12 years to less than (<) 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.

Conditions

Tinea Pedis; Tinea Cruris

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tinea Pedis

Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the ankles.

Group Type: EXPERIMENTAL

Luliconazole Cream 1%

Intervention Type: DRUG

Luliconazole cream will be applied topically per schedule specified in the arms.

Tinea Cruris

Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the groin, thighs, and abdomen.

Group Type: EXPERIMENTAL

Luliconazole Cream 1%

Intervention Type: DRUG

Luliconazole cream will be applied topically per schedule specified in the arms.

Interventions

Luliconazole Cream 1%

Luliconazole cream will be applied topically per schedule specified in the arms.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants (or legal guardian) with the ability and willingness to sign a written informed consent.
• Participants of either gender at least 12 years to <18 years old (12 to 17 years, inclusive).
• Participants with a mycological diagnosis of tinea pedis or tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount.
• Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, have all blood draws, and successfully complete the study.
• 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 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 both tinea pedis and tinea cruris.
• Participants with active atopic or contact dermatitis in the treatment area.
• 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 of test treatment will be discontinued from test treatment 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: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals

Locations

Valeant Site 01

Santo Domingo, , Dominican Republic

Valeant Site 02

San Pedro Sula, , Honduras

Countries

Dominican Republic; Honduras

Other Identifiers

V01-LUZA-401

Identifier Type: -

Identifier Source: org_study_id