Clinical trial NCT01712360: Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinea Pedis
Tinea Cruris
Keywords: Tinea Pedis
Tinea Cruris
Athlete foot
Jock itch
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 56
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

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

Primary outcomes:
measure: Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
timeFrame: Day 1 and Day 14
measure: Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
timeFrame: Day 1 and Day 14
Secondary outcomes:
measure: Efficacy Variables
timeFrame: Day 28
measure: Efficacy Variables
timeFrame: Day 28
Other outcomes:
Locations:
city: Austin
country: United States
facility: Merz Investigative Site #001272
state: Texas
city: College Station
country: United States
facility: Merz Investigative Site #001261
state: Texas
city: Santo Domingo
country: Dominican Republic
facility: Merz Investigative Site #180001
city: San Pedro Sula
country: Honduras
facility: Merz Investigative Site #504001
Study officials:
affiliation: Merz Pharmaceutical, LLC
name: Alan Fleischer, MD
role: STUDY_DIRECTOR
References: