Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified
Conditions
Interventions
Intervention1: SilverNova Skin Cream: Oral antifungals + Topical antifungal (morning) + Silvernova skin cream (evening)
Control Intervention1: Reference product: Oral antifungals + Topical antifungal
Sponsors
Viridis BioPharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female subjects age 18 or older, 2.Subjects having any one skin infection mentioned below caused by Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton floccosum: -Tinea corporis -Tinea cruris, -Tinea manus, -Tinea pedis infections, -Intertrigo 3.The sum of clinical signs and symptoms scores of the target lesion = 4. For scoring scale: a. Signs: Fissuring/cracking, erythema, maceration and scaling b. Symptoms: pruritus and burning/stinging In addition the target lesion must have a minimum score = 2 for erythema and a minimum score = 2 for either pruritus or scaling. 4.Subject who, in the opinion of the investigator, are free of any medical condition(s) that may interfere with study participation or affect study measures. a. Not pregnant, no systemic disease. b. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements. c. Patients who agreed to return for follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, lactating or planning to become pregnant during the study period. 2. History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months. 3. History of dermatophyte infections with a lack of response to antifungal therapy (recurrent tinea pedis [i.e., more than 3 infections in the past 12 months] that were unresponsive to previous antifungal therapy). 4. History of allergy, hypersensitivity, or intolerance to SilverNovaTM Skin Cream, or any other component of the study product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction of Clinical Signs and Symptoms of skin infection assessed by clinical examination from baseline to end of treatment 2 Proportion of patients in each group with a Therapeutic Cure in skin infection from baseline to end of treatmentTimepoint: 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-Assessment of General Health from baseline to End of treatent 2. IP Tolerance 3. Assessment of safety of the Investigational products by monitoring the adverse event. 4. Clear photographs to be taken before and after. Timepoint: 21 days | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio clinical research Pvt Ltd
Outcome results
None listed