Phase 3
N=290
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
Tinea Pedis
Bottom Line
View on ClinicalTrials.gov: NCT01433107 ↗Enrolled (actual)
290
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) — 73; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Terbinafine (Drug); Terbinafine Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) |
73; 10 | — |
| SECONDARY Total Clinical Signs and Symptoms (S/S) Scores |
1.6; 4.7 | — |
| SECONDARY Number of Subjects With Adverse Event |
9; 11 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01433107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.