Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
| Status: | Completed |
|---|---|
| Conditions: | Podiatry |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 10/3/2013 |
| Start Date: | October 2012 |
| End Date: | December 2013 |
| Contact: | Merz Pharmaceuticals, LLC |
| Email: | clinicaltrials@merzusa.com |
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
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 athlete's foot or to both feet and the groin area if the
subject have both athlete's foot and jock itch. Safety of the drug and how well the drug
works will also be measured.
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 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 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 KOH analysis from both feet. Both feet must be
characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4
PK evaluable adult subjects with the same condition will serve as a control.
Inclusion Criteria:
- Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500,
both conditions must be characterized by clinical evidence of a Tinea infection.
- Subjects must have Tinea pedis on both feet for NAFT-600, the condition must be
characterized by clinical evidence of a Tinea infection
Exclusion Criteria:
- A known hypersensitivity to study medications or their components.
- Any severe condition of Tinea pedis (incapacitating).
- Any dermatological disease and or condition in the treatment or surrounding area that
may prevent application of the study product such as foot psoriasis, corns and /or
callus involving any web spaces, atopic or contact dermatitis.
- Positive pregnancy test
- Any history or current evidence(physical or laboratory) of anemia.
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