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CTRI Number  CTRI/2022/06/043512 [Registered on: 27/06/2022] Trial Registered Prospectively
Last Modified On: 29/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to assess efficacy and safety of SilverNova skin cream in the treatment of fungal skin infections 
Scientific Title of Study   A Prospective, Interventional, Randomized, Parallel, Double blind, active-controlled, Clinical Study to evaluate the Efficacy & Safety of SilverNovaTM Skin Cream as an adjuvant to topical and oral antifungals in the treatment of fungal skin infections 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/CR/VBPL/0517/002 version 01 dated 17 May 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avinash Bajirao Jadhav 
Designation  MD - Dermatologist  
Affiliation  Jyoti Multispecialty Clinic 
Address  B-Wing, Shop No. 03, Sai Pritam Nagari Apartment, Kalewadi, Pune-17

Pune
MAHARASHTRA
413801
India 
Phone  7741970087  
Fax    
Email  dravinashjadhav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish S 
Designation  Director operation  
Affiliation  ICBio clinical research Pvt Ltd 
Address  #16 & 18, ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query  
Name  Dr Harish S 
Designation  Director operation  
Affiliation  ICBio clinical research Pvt Ltd 
Address  #16 & 18, ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
Viridis BioPharma Pvt. Ltd. 6/10, Jogani Industrial Complex, V N Purav Marg, Chunabhatti, Mumbai 400 022 
 
Primary Sponsor  
Name  Viridis BioPharma Pvt Ltd 
Address  Viridis BioPharma Pvt. Ltd. 6/10, Jogani Industrial Complex, V N Purav Marg, Chunabhatti, Mumbai 400 022  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avinash Bajirao Jadhav  Jyoti Multispecialty Clinic  B-Wing, Shop No. 03, Dermatology department Sai Pritam Nagari Apartment, Kalewadi, Pune-17
Pune
MAHARASHTRA 		 7741970087
72760747671
dravinashjadhav@gmail.com 
Dr Sanjay Purohit   Maven’s Hospital  Room no:2 ,Dermatology department N37, Vaishali Nagar, Ajmer 305001
Ajmer
RAJASTHAN 		 9829279052
01452642799
dr.sanjay.ajmer@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Mavens Institutional Ethics Committee  Approved 
Royal pune independent ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Reference product   Oral antifungals + Topical antifungal (twice a day i.e., in morning and evening)  
Intervention  SilverNova Skin Cream  Oral antifungals + Topical antifungal (morning) + Silvernova skin cream (evening) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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 treatment 		 21 days  
 
Secondary Outcome  
Outcome  TimePoints 
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.
 		 21 days  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/06/2022 
Date of Study Completion (India) 28/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Title of study: “A Prospective, Interventional, Randomized, Parallel, Double blind, active-controlled, Clinical Study to evaluate the Efficacy & Safety of SilverNovaTM Skin Cream as an adjuvant to  topical and oral antifungals in the treatment of fungal skin infections’’
Study Duration: Study duration of 21 Days , with 14  days treatment and followup on 21 day.
Number of subjects: 80 Subjects 
Objectives of the study: 
Primary Objective: To evaluate the efficacy of SilverNovaTM Skin Cream as an adjuvant to topical and oral antifungals in the treatment of fungal skin infections
Secondary Objetive: To evaluate the safety of SilverNovaTM Skin Cream as an adjuvant to topical and oral antifungals in the treatment of fungal skin infections.
 
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