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

Bausch Health

Status and phase: Completed; Phase 4

Conditions: Tinea Pedis; Tinea Cruris

Treatments: Drug: Luliconazole Cream 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02767271

V01-LUZA-401

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Tinea Pedis

Experimental group

Description:

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.

Treatment:

Drug: Luliconazole Cream 1%

Tinea Cruris

Experimental group

Description:

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.

Treatment:

Drug: Luliconazole Cream 1%