Topical Antifungal Treatment for Tinea Cruris

A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Cruris

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01342315

Enrollment

483

Registered

2011-04-27

Start date

2011-05-31

Completion date

2012-05-31

Last updated

2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Cruris

Keywords

Tinea Cruris, antifungal

Brief summary

To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris

Interventions

DRUG33525

Daily dosing

DRUGPlacebo

Daily dosing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* moderate erythema, mild scaling, and moderate pruritis

Exclusion criteria

* pregnancy and allergies

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients achieving complete clearance	3 weeks post-treatment	Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary

Measure	Time frame	Description
Proportion of patients achieving effective treatment	1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment	Clinical Cure and Mycological Cure

Countries

Belize, El Salvador, Honduras, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026