A Clinical Study to Assess the Effectiveness and Side effects of Naftifine Gel 2% in patients with fungal infection of foot

Phase 3

• Conditions: Health Condition 1: B353- Tinea pedis

• Registration Number: CTRI/2021/01/030753
• Lead Sponsor: Hetero Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified