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Sponsored by: |
Merz Pharmaceuticals, LLC |
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Information provided by: | Merz Pharmaceuticals, LLC |
ClinicalTrials.gov Identifier: | NCT00750139 |
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).
Condition | Intervention | Phase |
---|---|---|
Tinea Pedis Athlete's Foot |
Drug: NAFT-500 Drug: Placebo Drug: topical allylamine cream Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-500 in Subjects With Tinea Pedis |
Estimated Enrollment: | 650 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
NAFT-500
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Drug: NAFT-500
topical cream 1 application every day up to 4 weeks weeks
|
2: Placebo Comparator
Placebo
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Drug: Placebo
placebo cream 1 application every day for up tp 4 weeks
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3: Active Comparator
active comparator
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Drug: topical allylamine cream
topical allylamine cream applied once a day for up to 4 weeks
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4: Placebo Comparator
placebo
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Drug: placebo
topical placebo cream applied once a day for up to 4 weeks
|
To evaluate the efficacy and safety of NAFT-500 compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea pedis.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects using the following medications:
Contact: Rebecca Madura | 704-602-6702 | rmadura@pharmanet.com |
United States, Alabama | |
Radiant Research | Recruiting |
Birmingham, Alabama, United States, 35209 | |
Contact: Spencer Boddy 205-870-8803 spencerboddy@radiantresearch.com | |
Principal Investigator: JoLynne Herzog, MD | |
United States, California | |
University of California San Francisco, Dept of Dermatology | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Sarah Hiliker 415-885-3636 hilikers@derm.ucsf.edu | |
Principal Investigator: Raza Aly, PhD | |
Dr. Felix Sigal | Recruiting |
Los Angeles, California, United States, 90010-3209 | |
Contact: Kimberly Panizzon 213-365-0793 kpanizzon@yahoo.com | |
Principal Investigator: Felix Sigal, DPM | |
United States, Florida | |
FXM Research | Recruiting |
Miami, Florida, United States, 33175 | |
Contact: Francisco Moncada 305-220-5222 Francisco.moncada@fxmresearch.com | |
Principal Investigator: Hector Wiltz, MD | |
FXM Research | Recruiting |
Miramar, Florida, United States, 33027 | |
Contact: Francisco Moncada 954-430-1097 Francisco.moncada@fxmresearch.com | |
Principal Investigator: Francisco Flores, MD | |
United States, Illinois | |
Glazer Dermatology | Recruiting |
Buffalo Grove, Illinois, United States, 60089 | |
Contact: Bobbie Carrick 847-459-6611 bcarrick1201@yahoo.com | |
Principal Investigator: Scott Glazer, MD | |
United States, Louisiana | |
Tulane University Health Services | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Edward Coleman 504-988-5135 ecoleman@tulane.edu | |
Principal Investigator: Erin Boh, MD | |
United States, Michigan | |
Silverton Skin Institute | Recruiting |
Grand Blanc, Michigan, United States, 48439 | |
Contact: Elizabeth Niec 810-606-7500 e_niec@hotmail.com | |
Principal Investigator: Kimball Silverton, MD | |
United States, North Carolina | |
Zoe Draelos, MD | Recruiting |
High Point, North Carolina, United States, 27262 | |
Contact: Christina Hatch 336-841-2040 dcs@northstate.net | |
Principal Investigator: Zoe Draelos, MD | |
United States, Ohio | |
Haber Dermatology | Recruiting |
Euclid, Ohio, United States, 44118 | |
Contact: Janet Cohen 216-932-5200 haberresearch@gmail.com | |
Principal Investigator: Robert Haber, MD | |
United States, Oregon | |
Oregon Dermatology and Research Center | Recruiting |
Portland, Oregon, United States, 97210 | |
Contact: Bernie Severson 503-226-3376 bgseverson@cs.com | |
Principal Investigator: Phoebe Rich, MD | |
United States, Pennsylvania | |
Paddington Testing Company | Recruiting |
Philadelphia, Pennsylvania, United States, 19103 | |
Contact: Hirak Routh 215-563-7330 hirakbrouth@yahoo.com | |
Principal Investigator: Lawrence Parrish, MD | |
Temple University School of Podiatric Medicine | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Howard Palarmachuk 215-625-5252 | |
Principal Investigator: Tracey Vlahovic, DPM | |
United States, South Carolina | |
Coastal Carolina Research Center | Recruiting |
Mt. Pleasant, South Carolina, United States, 29464 | |
Contact: Terry Cunningham 843-856-3784 tcunningham@coastalcarolinaresearch.com | |
Principal Investigator: Cynthia Strout, MD | |
United States, Texas | |
Research Across America | Recruiting |
Plano, Texas, United States, 75093 | |
Contact: Enrique Echaniz 972-241-1222 eechaniz@researchacrossamerica.com | |
Principal Investigator: Jeffrey Adelglass, MD | |
J & S Studies | Recruiting |
College Station, Texas, United States, 77845 | |
Contact: Jeremy Scott 979-774-5933 jscott@js-studies.com | |
Principal Investigator: Terry Jones, MD |
Principal Investigator: | Lawrence Parish, MD | Paddington Testing Company |
Responsible Party: | Merz Phamraceuticals, LLC ( Clinical Project Manager ) |
Study ID Numbers: | MUS 90200-0736/1 |
Study First Received: | September 8, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00750139 |
Health Authority: | United States: Food and Drug Administration |
Tinea Pedis Athlete's foot |
Pruritus Signs and Symptoms Mycoses Tinea Pedis Skin Diseases, Infectious |
Skin Diseases Foot Diseases Tinea Dermatomycoses |
Skin Manifestations Foot Dermatoses Infection |