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NCT Number: NCT01433107

Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

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.

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Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatomycoses Foot Dermatoses Foot Diseases Infections Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing University Hospital N°3, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terbinafine

Drug

1% single application

Terbinafine Placebo

Drug

single application

Primary outcomes

  1. 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

    • = mild
    • = moderate
    • = severe In order to calculate the total symptoms score the rating for all symptoms are added up.

    Possible range 0 to 18

Secondary outcomes

  1. 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

    • = mild
    • = moderate
    • = severe In order to calculate the total symptom score, the scores for each individual symptom are added up.

    Possible range : 0 to 18

  2. Number of Subjects With Adverse Event

    Time frame: 6 weeks

    Number of Subjects with adverse event

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2011
Registry last updated
Dec 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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