Status:
COMPLETED
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
Lead Sponsor:
Novartis
Conditions:
Tinea Pedis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01433107
Start Date
August 1 2011
End Date
February 1 2012
Last Update
December 27 2013
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University First Hospital
Beijing, China, 100034
2
Beijing University Hospital N°3
Beijing, China, 100083
3
The Second Affiliated Hospital of Sun Yat-sen University Guangzhou
Guangdong, China, 510120
4
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China, 510630