CompletedPhase 3

Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris

United States334 participantsStarted 2008-09

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Review and sign a statement of Informed Consent and HIPAA authorization.
✓. 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.
✓. 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).
✓. 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.
✓. KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
✓. Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations.
✓. Subjects must be able to understand the requirements of the study and willing to comply with the study requirements.

Exclusion criteria

✕. A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
✕. 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.
✕. Subjects with a known hypersensitivity to study medications or their components.
✕. Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
✕. Uncontrolled diabetes mellitus.
✕. Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
✕. Current diagnosis of immunocompromising conditions.
✕. Atopic or contact dermatitis.

What they're measuring

Percentage of Subjects

Timeframe: Week 4 post-baseline

Trial details

NCT IDNCT00750152

SponsorMerz North America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2012-02-08

View on ClinicalTrials.gov More Tinea Cruris trials