Ignite Creation Date:
2024-05-06 @ 1:01 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01712360
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2012-10-16
Brief Title:
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
Sponsor:
Merz North America Inc
Organization:
Merz North America Inc
Study Overview
Official Title:
An Open-Label Multi-Center Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athletes foot or to both feet and the groin area if the subject has both athletes foot and jock itch Safety of the drug and how well the drug works will also be measured
Detailed Description:
Study population diagnosis and main criteria for inclusion
Tinea pedis and Tinea cruris NAFT-500
Male or non-pregnant female subjects aged 12 to 17 years 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide KOH analysis from both the feet and bikini area Both cases feet and bikini area must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection Additional approximately 4 pharmacokinetic PK evaluable adult subjects with the same condition will serve as a control
Tinea pedis NAFT-600
Male or non-pregnant female subjects aged 12 to 17 years 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide KOH analysis from both feet Both feet must be characterized by clinical evidence of a Tinea pedis infection Additional approximately 4 pharmacokinetic PK evaluable adult subjects with the same condition will serve as a control
Tinea pedis and Tinea cruris NAFT-500
Male or non-pregnant female subjects aged 12 to 17 years 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide KOH analysis from both the feet and bikini area Both cases feet and bikini area must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection Additional approximately 4 pharmacokinetic PK evaluable adult subjects with the same condition will serve as a control
Tinea pedis NAFT-600
Male or non-pregnant female subjects aged 12 to 17 years 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide KOH analysis from both feet Both feet must be characterized by clinical evidence of a Tinea pedis infection Additional approximately 4 pharmacokinetic PK evaluable adult subjects with the same condition will serve as a control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Tinea Pedis and Cruris | None | None | None |