Phase 4
Completed N=56
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
Tinea Pedis · Tinea Cruris
Source: ClinicalTrials.gov NCT01712360 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose — 138262.2; 15890.1; 68634.2; 17213.9 h*pg/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose |
9213.35; 1397.77; 3983.34; 1741.02; 12727.36; 3813.38 | — |
| SECONDARY Efficacy Variables |
81.8; 0; 86.4; 16.7; 54.5; 20.0 | — |
Eligibility Criteria
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, or atopic or contact dermatitis
- Positive pregnancy test
- Any history or current evidence (physical or laboratory) of anemia
Data sourced from ClinicalTrials.gov (NCT01712360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.