Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

Merz Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Tinea Pedis; Tinea Cruris

Treatments: Drug: NAFT600 (adult); Drug: NAFT600 (pediatric); Drug: NAFT500 (pediatric); Drug: NAFT500 (adult)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01712360

Tinea Pedis and Cruris

MUS 90200/1023/0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

NAFT500 (pediatric)

Experimental group

Description:

Topical once a day for two weeks

Treatment:

Drug: NAFT500 (pediatric)

NAFT600 (pediatric)

Experimental group

Description:

Topical once a day for two weeks

Treatment:

Drug: NAFT600 (pediatric)

NAFT500 (adult)

Experimental group

Description:

Topical once a day for two weeks

Treatment:

Drug: NAFT500 (adult)

NAFT600 (adult)

Experimental group

Description:

Topical once a day for two weeks

Treatment:

Drug: NAFT600 (adult)