Health Condition 1: B353- Tinea pedis
Conditions
Interventions
Intervention1: Naftifine Hydrochloride Gel 2%: Study medication to be applied to the affected and immediate surrounding area (an approximate 1- inch margin of healthy surrounding skin) morning and eve
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females 18-65 years of age 2. Patients with clinical diagnosis of tinea pedis 3. Patients with the sum of the clinical signs and symptoms scores of the target lesion is at least 5(on a scale of 0-3) 4. Patients with mycological diagnosis of interdigital tinea pedis
Exclusion criteria
Exclusion criteria: 1. Patients with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot 2. Patients with known hypersensitivity to Naftifine and/or to any component of the formulation 3. Patients who are immunocompromised (due to disease (HIV or medications) 4. Patients with uncontrolled diabetes mellitus (HbA1C >=8) at study entry 5. Patients using the following medications: - Use of antipruritics, including antihistamines, within 72hours prior to randomization - Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to randomization - Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to randomization - Use of oral terbinafine or itraconazole within 2 months prior to randomization - Use of immunosuppressive medication or radiation therapy within 3 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving clinical cureTimepoint: Week 6 (± 4 days) (study day 38-46) following 2 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving clinical cureTimepoint: Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment;Proportion of patients achieving complete clearanceTimepoint: Week 6 (± 4 days) (study day 38-46) and at Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment;Proportion of patients achieving mycological cureTimepoint: Week 6 (± 4 days) (study Day 38-46) and at Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment;Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: All Visits | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Labs Limited
Outcome results
None listed