Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Arm C: Luliconazole and Miconazole: Arm C: Concomitant application of Luliconazole 1 percent w/w and Miconazole 2 percent w/w (mixed
immediately prior to use) applied once daily for 2
Sponsors
Dr Rajkumar Kothiwala
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 to 65 years. 2. Clinical diagnosis of superficial dermatophytosis (Tinea corporis and/or Tinea cruris). 3. Diagnosis confirmed by positive potassium hydroxide (KOH) microscopy at screening. 4. Presence of at least one measurable lesion (2 10 cm in diameter). 5. Mild to moderate severity of infection suitable for topical therapy. 6. Willingness to comply with study procedures and visit schedule. 7. Ability to understand the study requirements. 8. Provision of written informed consent prior to any study-related procedures.
Exclusion criteria
Exclusion criteria: 1 Presence of tinea capitis, onychomycosis, or extensive dermatophytosis (greater than 10 percent body surface area). 2 Evidence of secondary bacterial infection at the target lesion requiring systemic antibiotic therapy. 3 Use of systemic antifungal therapy within 4 weeks prior to screening. 4 Use of topical antifungal or topical corticosteroid therapy within 2 weeks prior to screening. 5 Known hypersensitivity or allergic reaction to azole antifungals, including Luliconazole or Miconazole. 6 Immunocompromised status (e.g., uncontrolled diabetes, HIV infection, long-term immunosuppressive therapy). 7 Pregnant or lactating women, or women planning pregnancy during the study period. 8 Participation in another clinical trial within 30 days prior to screening. 9 Any serious medical condition that, in the opinion of the investigator, may interfere with study participation or evaluation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Luliconazole, Miconazole, and Their Combination in Subjects with Superficial Dermatophytosis (Tinea Corporis and/or Tinea Cruris).Timepoint: at day 14 (week 2), efficacy assessment will be done | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety & tolerability of Luliconazole, Miconazole, & Their Combination in Subjects with Superficial Dermatophytosis (Tinea Corporis and/or Tinea Cruris).Timepoint: At week 2, Day 14 safety assessment will be performed | — |
Countries
India
Contacts
Public ContactSandeep Yadav
Head of Department - Dermatology
Outcome results
None listed