NCT02633813

Brief Summary

The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
693

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_3

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

December 11, 2015

Last Update Submit

May 9, 2017

Conditions

Tinea Pedis

Keywords

BioequivalenceTinea pedisNaftin

Outcome Measures

Primary Outcomes (1)

  • Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum

    After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure.

    week 6 + 4 days

Secondary Outcomes (1)

  • Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum

    week 6 + 4 days

Other Outcomes (1)

  • Assessment of AEs for each treatment groups

    week 6 + 4 days

Study Arms (3)

Naftifine hydrochloride 2%

EXPERIMENTAL

A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.

Drug: Naftifine hydrochloride 2%

Naftin® 2% (Naftifine hydrochloride 2%)

ACTIVE COMPARATOR

A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.

Drug: Naftin® 2% (Naftifine hydrochloride 2%)

Placebo vehicle cream.

PLACEBO COMPARATOR

A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.

Drug: Placebo

Interventions

Naftifine hydrochloride 2%DRUG

Topical application for two weeks

Also known as: Naftifine hcl
Naftifine hydrochloride 2%
PlaceboDRUG

Topical application for two weeks

Also known as: Vehicle cream
Placebo vehicle cream.
Naftin® 2% (Naftifine hydrochloride 2%)DRUG

Topical application for two weeks

Also known as: Naftifine hcl
Naftin® 2% (Naftifine hydrochloride 2%)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males and females aged more than or equal to 18 years
  • Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
  • The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)

You may not qualify if:

  • Pregnant or lactating or planning to become pregnant during the study period
  • Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
  • Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
  • Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
  • Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
  • Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
  • Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
  • Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
  • History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
  • Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Moore Clinical Research Inc

Brandon, Florida, 33511, United States

Location

Savin Medical Group Research

Miami, Florida, 33014, United States

Location

International Dermatology Research, Inc,

Miami, Florida, 33144, United States

Location

FXM Research Corp

Miami, Florida, 33175, United States

Location

FXM Research Miramar

Miramar, Florida, 33027, United States

Location

South Tampa, MOORE Clinical Research, Inc.

Tampa, Florida, 33609, United States

Location

North Tampa MOORE Clinical Research, Inc.

Tampa, Florida, 33618, United States

Location

Medi Search

Saint Joseph, Missouri, 64506, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Family Practise

Mesquite, Texas, 75149, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Instituto Dermatológico y Cirugía de Piel

Santo Domingo, San Cristóbal, 91000, Dominican Republic

Location

Instituto Dermatológico

Barrio Maria Auxiliadora, Santo Domingo Province, 10305, Dominican Republic

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

naftifine

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zaidoon Al-Zubaidy

    Catawba Research

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2015

First Posted

December 17, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

DO(2)US(12)