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