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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01433107
Other study ID # 727-D-301
Secondary ID
Status Completed
Phase Phase 3
First received September 8, 2011
Last updated December 3, 2013
Start date August 2011
Est. completion date February 2012

Study information

Verified date December 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Terbinafine
1% single application
Terbinafine Placebo
single application

Locations

Country Name City State
China Beijing University Hospital N°3 Beijing
China Peking University First Hospital Beijing
China The Second Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
China The Third Affiliated Hospital of Sun Yat-sen University Guangzhou
China Chinese Academy of Medical Sciences Jiangsu
China Huashan Hospital, Fudan University Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
= mild
= moderate
= severe In order to calculate the total symptoms score the rating for all symptoms are added up.
Possible range 0 to 18
week 6 No
Secondary Total Clinical Signs and Symptoms (S/S) Scores 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
week 6 No
Secondary Number of Subjects With Adverse Event Number of Subjects with adverse event 6 weeks Yes
See also
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Completed NCT03897257 - A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis Phase 2
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1