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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00750139
First received: September 8, 2008
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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 2-weeks
Drug: Naftin 1%
Drug: Placebo 4-weeks
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Percentage of Subjects With Complete Cure at Week 6. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

    The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6.

    The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6.

    Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale.



Secondary Outcome Measures:
  • Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.


Enrollment: 707
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Naftin 2% cream applied daily for 2 weeks
Drug: NAFT-500
topical cream 1 application every day up to 4 weeks weeks
Other Name: NAFT-500
Placebo Comparator: 2
Placebo cream applied daily for two weeks
Drug: Placebo 2-weeks
placebo cream 1 application every day for up to 4 weeks
Active Comparator: 3
Active comparator applied daily for 4 weeks
Drug: Naftin 1%
topical allylamine cream applied once a day for up to 4 weeks
Placebo Comparator: 4
placebo cream applied daily for 4 weeks
Drug: Placebo 4-weeks
topical placebo cream applied once a day for up to 4 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Review and sign a statement of Informed Consent and HIPAA authorization.
  2. 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).
  3. 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.
  4. Presence of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus)based on signs and symptoms.
  5. KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
  6. Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations.
  7. Subject must be able to understand the requirements of the study and willing to comply with the study requirements.

Exclusion Criteria:

  1. A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
  2. 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.
  3. Subjects with a known hypersensitivity to study medications or their components.
  4. Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
  5. Uncontrolled diabetes mellitus.
  6. Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
  7. Current diagnosis of immunocompromising conditions.
  8. Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
  9. Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis, or bacterial skin infection.
  10. Extremely severe tinea pedis (incapacitating).
  11. Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study (females who are surgically sterilized or post menopausal for at least 2 years are not considered to be of childbearing potential).For the purposes of this study, acceptable forms of birth control include: oral contraceptives, contraceptive patches/implants, double barrier methods (e.g., use of condom and spermicide), IUD, and abstinence with second acceptable method should subject become sexually active.
  12. Subjects using the following medications:

    • Topical anti-fungal therapy, foot/shoe powders, or topical corticosteroids applied to the feet within 14 days prior to randomization. Topical terbinafine, butenafine,and naftifine within 30 days prior to randomization
    • Oral anti-fungal therapies 3 months (8 months for oral terbinafine) prior to randomization
    • Systemic antibiotic or corticosteroid treatment within 30 days of randomization
    • Any other significant treatments, except hormonal contraception and multivitamin, at the discretion of the investigator that would interfere with study treatment.
    • Investigational drug within 30 days of randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750139

Locations
United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
United States, California
Dr. Felix Sigal
Los Angeles, California, United States, 90010-3209
University of California San Francisco, Dept of Dermatology
San Francisco, California, United States, 94115
United States, Florida
FXM Research
Miami, Florida, United States, 33175
FXM Research
Miramar, Florida, United States, 33027
United States, Illinois
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
United States, Louisiana
Tulane University Health Services
New Orleans, Louisiana, United States, 70112
United States, Michigan
Silverton Skin Institute
Grand Blanc, Michigan, United States, 48439
United States, North Carolina
Zoe Draelos, MD
High Point, North Carolina, United States, 27262
United States, Ohio
Haber Dermatology
Euclid, Ohio, United States, 44118
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
Paddington Testing Company
Philadelphia, Pennsylvania, United States, 19103
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
J & S Studies
College Station, Texas, United States, 77845
Research Across America
Dallas, Texas, United States, 75234
Research Across America
Plano, Texas, United States, 75093
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Lawrence Parish, MD Paddington Testing Company
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00750139     History of Changes
Other Study ID Numbers: MUS 90200-0736/1
Study First Received: September 8, 2008
Results First Received: February 13, 2012
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merz Pharmaceuticals, LLC:
Tinea Pedis
Athlete's foot

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Foot Dermatoses
Foot Diseases
Infection
Mycoses
Pruritus
Signs and Symptoms
Skin Diseases
Skin Diseases, Infectious
Skin Manifestations

ClinicalTrials.gov processed this record on October 29, 2014