An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

Merz Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Tinea Corporis

Treatments

Drug: Naftin® Cream, 2% (older pediatric cohort)

Drug: Naftin® Cream, 2% (younger pediatric cohort)

Study type

Interventional

Funder types

Industry

Identifiers

MUS90200_4025_1

Details and patient eligibility

About

This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.

Enrollment

27 patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.
Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.
KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.
Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.

Exclusion criteria

Tinea infection of the scalp, face, groin, and/or feet.
A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months
Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
Subjects with a known hypersensitivity or other contradictions to study medications or their components.