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Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01289015
First received: January 28, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.


Condition Intervention Phase
Tinea Pedis
 Drug: NAFT-600
Drug: Placebo
 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-600 in Subjects With Tinea Pedis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Complete cure of interdigital tinea pedis [ Time Frame: Visit 4/ Week 6 ] [ Designated as safety issue: No ]

    The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.

    Complete cure is defined as:

    1. mycological cure (i.e. negative dermatophyte culture and negative KOH) and
    2. clinical cure (i.e. absence of erythema, scaling and pruritus {scores of 0, each}).


Secondary Outcome Measures:
  • Effective treatment of interdigital tinea pedis [ Time Frame: Visit 4/ Week 6. ] [ Designated as safety issue: Yes ]

    Effective treatment of interdigital tinea pedis; treatment is defined as mycological cure(negative dermatophyte culture and negative KOH) and clinical success(erythema, scaling and pruritus scores of 0 or 1 {absent or mild}).

    Other endpoints: Complete cure, effective treatment, and mycological cure of moccasin tinea pedis at Week 6.

    Safety Variables: Type, incidence, severity, timing, and relationship of adverse events (local and systemic)collected at each visit, laboratory tests (Day 1, Week 2,Week 6), and vital signs (Day 1,Week 6).



Enrollment: 849
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NAFT-600 Drug: NAFT-600
Topical; applied once daily for two weeks
Placebo Comparator: Placebo Drug: Placebo
Topical; applied once daily for two weeks

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
  • Presence of interdigital only or both interdigital and moccasin types 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 in the affected area(s)).

Exclusion Criteria:

  • Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer,unstable angina or myocardial infarction) within the last 6 months.
  • 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.
  • Subjects with a known hypersensitivity to study drugs or their components.
  • Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
  • Uncontrolled diabetes mellitus.
  • Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
  • Current diagnosis of immunocompromising conditions.
  • Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
  • Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.
  • Extremely severe tinea pedis (incapacitating).
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289015

  Show 23 Study Locations
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Lawrence Parish, MD Paddington Testing Co., Inc.
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01289015     History of Changes
Other Study ID Numbers: MRZ 90200/3015/1
Study First Received: January 28, 2011
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merz Pharmaceuticals, LLC:
fungal infection
athlete foot

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

ClinicalTrials.gov processed this record on May 21, 2013