- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433107
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of Terbinafine Film Forming Solution, 1% (as Hydrochloride), in Patients With Tinea Pedis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100034
- Peking University First Hospital
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Beijing, China, 100083
- Beijing University Hospital N°3
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Guangdong, China, 510120
- The Second Affiliated Hospital of Sun Yat-sen University Guangzhou
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Guangzhou, China, 510630
- The Third Affiliated Hospital of Sun Yat-sen University
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Jiangsu, China, 21004
- Chinese Academy of Medical Sciences
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Shanghai, China, 200040
- Huashan Hospital, Fudan University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign & symptom score and positive microscopy
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Drug
|
single application
|
Experimental: Terbinafine
Drug
|
1% single application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)
Time Frame: week 6
|
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
Possible range 0 to 18 |
week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Clinical Signs and Symptoms (S/S) Scores
Time Frame: week 6
|
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
Possible range : 0 to 18 |
week 6
|
Number of Subjects With Adverse Event
Time Frame: 6 weeks
|
Number of Subjects with adverse event
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Foot Diseases
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Mycoses
- Skin Manifestations
- Dermatomycoses
- Foot Dermatoses
- Pruritus
- Tinea
- Tinea Pedis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antifungal Agents
- Terbinafine
Other Study ID Numbers
- 727-D-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tinea Pedis
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National institute of SiddhaCompletedTinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are StudiedIndia
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Taro Pharmaceuticals USATerminated
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DermBiont, Inc.TerminatedInterdigital Tinea PedisDominican Republic
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AmDermaAmDerma Pharmaceuticals, LLCCompletedInterdigital Tinea PedisUnited States
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Ahmed A. H. AbdellatifUnknownFoot Infection Tinea PedisEgypt
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NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences...CompletedOnychomycosis/Onycholysis and Tinea PedisUnited States
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Tinea PharmaceuticalsCompletedTinea Pedis | Tinea Cruris | Tinea CorporisUnited States, Puerto Rico, El Salvador, Belize, Honduras
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Therapeutics, Inc.RecruitingTinea Pedis | Tinea CrurisUnited States
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Bausch & Lomb IncorporatedBausch Health Americas, Inc.CompletedTinea Pedis | Tinea CrurisUnited States
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Bausch Health Americas, Inc.CompletedTinea Pedis | Tinea CrurisDominican Republic, Honduras
Clinical Trials on Terbinafine
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NovartisCompletedHIV Infections | Candidiasis, OralUnited States
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Nitric BioTherapeutics, IncCompletedOnychomycosisUnited States, Canada
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BCDiabetes.CaBritaMed, Inc.Unknown
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Hallux, Inc.Active, not recruitingOnychomycosis of ToenailUnited States
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Novartis PharmaceuticalsCompletedOnychomycosisUnited States, France, Germany
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Nitric BioTherapeutics, IncCompleted
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Novartis PharmaceuticalsCompleted