Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Amorolfine lotion 0.25% w/v of M/s. Zydus Healthcare Ltd.: The study drug will be applied topically as a thin layer over the affected skin area(s) once daily for 4 weeks treatment durat
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender of 18 to 65 years of age (both inclusive) 2. Patients with acute symptomatic tinea corporis or tinea cruris limited to single body region and with limited involvement i.e., 3. Mycological diagnosis of tinea corporis or tinea cruris confirmed by detection of fungal hyphae on a microscopic KOH test 4. Patients with total clinical score of at least 5 5. Patients willing to provide written informed consent and comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Patients with history of hypersensitivity to amorolfine 2. Patients with extensive or disseminated tinea infections 3. Patients with tinea infection other than tinea corporis or tinea cruris 4. Patients with diagnosis of tinea infection requiring systemic treatment according to the severity of lesion as judged by the investigator 5. Patients having skin lesions with secondary bacterial infection 6. Patients with other dermatological conditions which may confound the disease assessment and treatment evaluation e.g., contact dermatitis, atopic dermatitis, psoriasis, urticaria 7. Patients with clinically significant uncontrolled systemic diseases such as gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine or hematological disorders or malignancy 8. Patients with immunosuppressive disorder e.g., HIV infection or patients on immunosuppressive medications e.g., systemic corticosteroids or cytotoxic drugs 9. Patients with hepatic dysfunction (serum transaminases � 3 x Upper Normal Limit) or renal dysfunction (serum creatinine � 2.5 mg/dl) 10. Patients who have used the following medications: a. Topical antifungal agent within 30 days prior to enrollment b. Systemic antifungal agent within 8 weeks (8 months for oral terbinafine) prior to enrollment c. Topical corticosteroid on the affected area(s) within 30 days prior to enrollment d. Systemic corticosteroids within 30 days prior to enrollment e. Systemic antihistamine agent within 3 days prior to enrollment f. Any other topical treatment on the affected area(s) within 7 days prior to enrollment 11. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 12. Patients with history of alcohol and/or drug abuse 13. Participation in another clinical trial in the past 3 months prior to screening 14. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure at the end of the treatmentTimepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and mycological relapse during the post-treatment follow-upTimepoint: Day 42;Composite cure at the end of the treatmentTimepoint: Day 28;Global assessment of efficacy at the end of the treatmentTimepoint: Day 28;Mycological cure at the end of the treatmentTimepoint: Day 28 | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Zydus Healthcare Limited
Outcome results
None listed