Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris
Condition: Tinea Cruris; Jock Itch
MeSH terms: Tinea; Tinea cruris
Intervention: NAFT-500; Placebo
Intervention description: topical cream application up to 4 weeks; placebo cream applied for up to 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 334.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tinea cruris; jock itch

Summary:

      A research study to compare the safety and effectiveness of an investigational medication
      called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris,
      also known as jock itch.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Review and sign a statement of Informed Consent and HIPAA authorization.

          2. Males or non-pregnant females ≥12 years of age, of any race or sex. Females of
             childbearing potential must have a negative urine pregnancy test.

          3. For minors (less than 18 years), the parent/legal guardian must complete the informed
             consent process AND the subject must complete the assent process and sign the
             appropriate form (if age appropriate).

          4. Presence of tinea cruris characterized by clinical evidence of a tinea infection (at
             least moderate erythema, moderate scaling, and mild pruritus) as confirmed by signs
             and symptoms.

          5. KOH positive and culture positive baseline skin scrapings obtained from the site most
             severely affected or a representative site of the overall severity.

          6. Subjects must be in good health and free from any clinically significant disease that
             might interfere with the study evaluations.

          7. Subjects must be able to understand the requirements of the study and willing to
             comply with the study requirements.

        Exclusion Criteria:

          1. A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable
             angina, or myocardial infarction) within the last 6 months.

          2. Subjects with abnormal findings - physical or laboratory - that are considered by the
             investigator to be clinically important and indicative of conditions that might
             complicate interpretation of study results.

          3. Subjects with a known hypersensitivity to study medications or their components.

          4. Subjects who have a recent history or who are currently known to abuse alcohol or
             drugs.

          5. Uncontrolled diabetes mellitus.

          6. Hemodialysis or chronic ambulatory peritoneal dialysis therapy.

          7. Current diagnosis of immunocompromising conditions.

          8. Atopic or contact dermatitis.

          9. Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.

         10. Female subject who is pregnant or lactating, who is not using or does not agree to use
             an acceptable form of contraception during the study, or who intends to become
             pregnant during the study (females who are surgically sterilized or post menopausal
             for at least 2 years are not considered to be of childbearing potential). For the
             purposes of this study,acceptable forms of birth control include: oral contraceptives,
             contraceptive patches/implants, double barrier methods (e.g., use of condom and
             spermicide), IUD, and abstinence with second acceptable method should subject become
             sexually active.

         11. Subjects using the following medications:

               -  Topical anti-fungal therapy, powders or topical corticosteroids applied within 14
                  days prior to randomization. Terbinafine, butenafine, and naftifine (topical)
                  within 30 days prior to randomization.

               -  Oral anti-fungal therapies within 3 months of randomization (8 months for oral
                  terbinafine).

               -  Systemic antibiotic or corticosteroid treatment within 30 days of randomization.

               -  Any other significant treatments, except hormonal contraception and multivitamin,
                  at the discretion of the investigator that would interfere with study treatment.

               -  Investigational drug/ device within 30 days of randomization