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NCT01396785 Clinical Trial

Topical Antifungal Treatment for Tinea Pedis

Tinea Pedis 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 Pedis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01396785
Other study ID # MP-1000-02
Secondary ID
Status Completed
Phase Phase 3
First received July 15, 2011
Last updated August 20, 2013
Start date July 2011
Est. completion date March 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

The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.

Recruitment information / eligibility
Status Completed
Enrollment 321
Est. completion date March 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Moderate erythema, moderate scaling, and mild pruritus

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 for 14 days
• Placebo
Daily for 14 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medicis Global Service Corporation

Countries where clinical trial is conducted

United States,  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 Day 42 No
Secondary Proportion of patients achieving effective treatment Clinical Cure and Mycologic Cure Day 42 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05493488 - A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis Phase 2
Completed NCT04883593 - A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis. Early Phase 1
Terminated NCT02842021 - Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis Phase 2
Completed NCT01712360 - Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Phase 4
Completed NCT00781664 - Cumulative Irritation Test Phase 1
Completed NCT03676686 - Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis N/A
Completed NCT01519752 - A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis Phase 1
Completed NCT03320486 - Non-inferiority Trial of Dapaconazole Versus Ketoconazole Phase 3
Completed NCT01580891 - Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis Phase 1
Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis Phase 3
Completed NCT01353976 - Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis Phase 3
Completed NCT04265521 - Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet N/A
Completed NCT02633813 - BE Study of Naftifine HCL Phase 3
Recruiting NCT00856596 - Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females Phase 3
Completed NCT00869336 - Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot) Phase 2
Completed NCT00768599 - A Study of Econazole Foam 1% in Athlete's Foot Phase 2
Recruiting NCT00233493 - Spread of Dermatophytes Among Families N/A
Completed NCT03897257 - A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis Phase 2
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1