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

Tracking Information

First Received Date ^ICMJE

January 28, 2011

Last Updated Date

April 22, 2013

Start Date ^ICMJE

February 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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:

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01289015 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Tinea Pedis

Intervention ^ICMJE

Drug: NAFT-600
Topical; applied once daily for two weeks
Drug: Placebo
Topical; applied once daily for two weeks

Study Arm (s)

Experimental: NAFT-600
Intervention: Drug: NAFT-600
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

849

Completion Date

January 2012

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT Number ^ICMJE

NCT01289015

Other Study ID Numbers ^ICMJE

MRZ 90200/3015/1

Has Data Monitoring Committee

Responsible Party

Merz Pharmaceuticals, LLC

Study Sponsor ^ICMJE

Merz Pharmaceuticals, LLC

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lawrence Parish, MD

Paddington Testing Co., Inc.

Information Provided By

Merz Pharmaceuticals, LLC

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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