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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01290341
Other study ID # MRZ 90200/3016/1
Secondary ID
Status Completed
Phase Phase 3
First received January 28, 2011
Last updated July 26, 2013
Start date February 2011
Est. completion date December 2011

Study information

Verified date July 2013
Source Merz Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.


Description:

This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.


Recruitment information / eligibility

Status Completed
Enrollment 860
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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.

- 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).

- 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
NAFT-600 (naftin 2 % gel)
Topical; applied once daily for two weeks
Placebo
Topical; applied once daily for two weeks.

Locations

Country Name City State
United States Academic Dermatology Associates Albuquerque New Mexico
United States DermResearch, Inc. Austin Texas
United States Radiant Research, Inc Cincinnati Ohio
United States Tampa Bay Medical Research Clearwater Florida
United States J&S Studies, Inc. College Station Texas
United States Radiant Research, Inc. Columbus Ohio
United States Research Across America Dallas Texas
United States Colorado Medical Research Center Denver Colorado
United States T. Joseph Raoof, MD, Inc. Encino California
United States Hudson Dermatology Evansville Indiana
United States Longmont Clinic, PC Longmont Colorado
United States The Education and Research Foundation, Inc. Lynchburg Virginia
United States Madison Skin and Research, Inc Madison Wisconsin
United States Lake Washington Foot and Ankle Center Melbourne Florida
United States Department of Veterans Affairs Minneapolis Minnesota
United States Temple University- School of Podiatric Medicine Philadelphia Pennsylvania
United States Oregon Dermatology & Research Center Portland Oregon
United States Endeavor Clinical Trials, PA San Antonio Texas
United States Progressive Clinical Research San Antonio Texas
United States Walter K. Nahm, MD, PhD, Inc. San Diego California
United States Palmetto Clinical Trial Services, LLC Simpsonville South Carolina
United States Clinical Research Atlanta Stockbridge Georgia
United States Radiant Research, Inc. Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Cure of Interdigital Tinea Pedis 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 negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.
Visit 4/ Week 6 No
Secondary Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).
Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture.
Visit 4/ Week 6 No
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