Clinical Trials Logo
  1. Home
  2. Tinea Cruris
  3. NCT01342315
  4. Details
NCT01342315 Clinical Trial

Topical Antifungal Treatment for Tinea Cruris

Tinea Cruris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01342315
Other study ID # MP-1000-01
Secondary ID
Status Completed
Phase Phase 3
First received April 25, 2011
Last updated August 20, 2013
Start date May 2011
Est. completion date May 2012

Study information
Verified date August 2013
Source Medicis Global Service Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 483
Est. completion date May 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria:

- pregnancy and allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 33525
Daily dosing
• Placebo
Daily dosing

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medicis Global Service Corporation

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients achieving complete clearance Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture 3 weeks post-treatment No
Secondary Proportion of patients achieving effective treatment Clinical Cure and Mycological Cure 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment No
See also
  Status Clinical Trial Phase
Completed NCT00750152 - Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris Phase 3
Completed NCT01712360 - Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Phase 4
Not yet recruiting NCT05881980 - Efficacy and Safety of Terbinafine and Itraconazole Phase 2/Phase 3
Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis Phase 3
Completed NCT03359070 - Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris Phase 2
Completed NCT02394340 - Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris Phase 4
Completed NCT05363449 - Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis Phase 1
Completed NCT02767271 - Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris Phase 4
Completed NCT01885156 - Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris Phase 3
Not yet recruiting NCT01105013 - Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections Phase 3