An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

Tinea Corporis Clinical Trial

Official title:

An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466867
• Other study ID #: MUS90200_4025_1
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2014
• Last updated: October 27, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Corporis

Intervention

Drug:
• Naftin® Cream, 2% (younger pediatric cohort)
Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.
• Naftin® Cream, 2% (older pediatric cohort)
Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.

Locations

Country	Name	City	State
Dominican Republic	Merz Investigative Site#180001	Santo Domingo
Honduras	Merz Investigative Site #504001	San Pedro Sula
United States	Merz Investigative Site#001261	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Countries where clinical trial is conducted

United States,  Dominican Republic,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis	AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D	2 weeks	No
Secondary	Evaluate plasma PK single and multiple dose PK variables	tmax and tmax,ss	2 weeks	No
Secondary	Evaluate trough plasma PK concentration	Ctrough, ttrough,max, Ctrough,max	2 weeks	No
Secondary	Evaluate urine PK single and multiple dose variables	Ae0-24, fe, CLR, AEt,ss	2 weeks	No