Clinical study to assess efficacy and safety of SilverNova skin cream in the treatment of fungal skin infections

Not Applicable

Completed

• Conditions: Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified

• Registration Number: CTRI/2022/06/043512
• Lead Sponsor: Viridis BioPharma Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-28
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified