An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

Phase 4

Completed

• Conditions: Tinea Corporis
• Interventions: Drug: Naftin® Cream, 2% (younger pediatric cohort); Drug: Naftin® Cream, 2% (older pediatric cohort)

• Registration Number: NCT02466867
• Lead Sponsor: Merz North America, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-09
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2016-10
• Disposition First Submitted: 2016-10-27
• Disposition First Submitted QC: 2016-10-27
• Last Update Submitted: 2016-10-27
• Disposition First Posted: 2016-10-28
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naftin® Cream, 2% (younger pediatric cohort)	Naftin® Cream, 2% (younger pediatric cohort)	Subject aged 2 years to 5 years, 11 months with tinea corporis
Naftin® Cream, 2% (older pediatric cohort)	Naftin® Cream, 2% (older pediatric cohort)	Subject aged 6 years to 11 years, 11 months with tinea corporis

Primary Outcome Measures

Name	Time	Method
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis	2 weeks	AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D

Secondary Outcome Measures

Name	Time	Method
Evaluate urine PK single and multiple dose variables	2 weeks	Ae0-24, fe, CLR, AEt,ss
Evaluate plasma PK single and multiple dose PK variables	2 weeks	tmax and tmax,ss
Evaluate trough plasma PK concentration	2 weeks	Ctrough, ttrough,max, Ctrough,max

Trial Locations

Locations (3)

Merz Investigative Site #504001; 🇭🇳 San Pedro Sula, Honduras

Merz Investigative Site#001261; 🇺🇸 College Station, Texas, United States

Merz Investigative Site#180001; 🇩🇴 Santo Domingo, Dominican Republic