CTRI/2022/03/041466
Active, not recruiting
Phase 3
A prospective, randomized, two-arm, double-blind, active-controlled, parallel, multicentre, non-inferiority, phase III clinical trial to assess the efficacy and safety of Naftifine hydrochloride cream 2% w/w as compared to Terbinafine hydrochloride cream 1% w/w in patients with superficial fungal infection of the skin
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zydus Healthcare Limited
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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., \< 5 skin lesions with each having greatest diameter of \< 5 cm
- •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
- •1\. Patients with history of hypersensitivity to naftifine or terbinafine
- •2\. Patients with extensive or disseminated tinea infections
- •3\. Patients with tinea infection other than tinea corporis or tinea cruris such as tinea infection of face, scalp or feet
- •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
Outcomes
Primary Outcomes
Not specified
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