NCT01433107

Brief Summary

This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

6 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

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 27, 2013

Completed
Last Updated

December 27, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

September 8, 2011

Results QC Date

April 8, 2013

Last Update Submit

December 3, 2013

Conditions

Tinea Pedis

Keywords

Tinea pedisTerbinafine film forming solution

Outcome Measures

Primary Outcomes (1)

  • Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)

    Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18

    week 6

Secondary Outcomes (2)

  • Total Clinical Signs and Symptoms (S/S) Scores

    week 6

  • Number of Subjects With Adverse Event

    6 weeks

Study Arms (2)

Terbinafine

EXPERIMENTAL

Drug

Drug: Terbinafine

Placebo

PLACEBO COMPARATOR

Drug

Drug: Terbinafine Placebo

Interventions

TerbinafineDRUG

1% single application

Terbinafine
Terbinafine PlaceboDRUG

single application

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy

You may not qualify if:

  • Allergy to the allylamine class of antimycotics or excipients in the formulation.
  • Chronic, hyperkeratotic plantar (moccasin) tinea pedis
  • Other fungal disease or intertrigo
  • Other abnormal findings on the affected foot
  • Systemic antifungal or antimicrobial treatment within the last 3 months
  • Topical treatment for skin lesions on feet within the last 3 months
  • Diabetes mellitus and peripheral artery occlusive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Peking University First Hospital

Beijing, 100034, China

Location

Beijing University Hospital N°3

Beijing, 100083, China

Location

The Second Affiliated Hospital of Sun Yat-sen University Guangzhou

Guangdong, 510120, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510630, China

Location

Chinese Academy of Medical Sciences

Jiangsu, 21004, China

Location

Huashan Hospital, Fudan University

Shanghai, 200040, China

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Clinical Project leader
Organization
Novartis
+41223633111

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 13, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

December 27, 2013

Results First Posted

December 27, 2013

Record last verified: 2013-12

Locations

CN(6)