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CTRI Number  CTRI/2025/12/099526 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Can Adding a Healing Cream Help Treat Fungal Skin Infections Better 
Scientific Title of Study   A randomized, open label, prospective investigator initiated interventional study to understand the effects of addition of broad-spectrum antimicrobial skin healing cream (Silversol plus coconut oil plus vitamin E plus Hyaluronic acid) as an adjuvant to an antifungal agent in the management of superficial skin fungal infections. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
KMCRI/DERMA/2025/001  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mitaxari Hugar 
Designation  Consultant  
Affiliation  Karnataka Medical college 
Address  Department of Skin & STD, KMCRI, Hubballi, Karnataka.
Vidyanagar Hubballi 5800021
Dharwad
KARNATAKA
580021
India 
Phone  9885712333  
Fax    
Email  drmita333@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mitaxari Hugar 
Designation  Consultant  
Affiliation  Karnataka Medical college 
Address  Department of Skin & STD, KMCRI, Hubballi, Karnataka.
Vidyanagar Hubballi 5800021
Dharwad
KARNATAKA
580021
India 
Phone  9885712333  
Fax    
Email  drmita333@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mitaxari Hugar 
Designation  Consultant  
Affiliation  Karnataka Medical college 
Address  Department of Skin & STD, KMCRI, Hubballi, Karnataka.
Vidyanagar Hubballi 5800021
Dharwad
KARNATAKA
580021
India 
Phone  9885712333  
Fax    
Email  drmita333@gmail.com  
 
Source of Monetary or Material Support  
Docmode Health Technologies Ltd 
 
Primary Sponsor  
Name  Docmode Health Technologies Ltd 
Address  307 - Shivai Plaza, Marol Cooperative Industrial Estate Rd. Gamdevi, Marol, Andheri East, Mumbai - 400059, Maharashtra 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mitaxari Hugar  KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE, HUBBALLI  Bengaluru, Karnataka
Dharwad
KARNATAKA 		 9885712333

drmita333@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE,  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Silversol plus  Silversol plus coconut oil plus vitamin E plus Hyaluronic acid) as an adjuvant to an antifungal agent in the management of superficial skin fungal infections.Like topical antifungal, broad-spectrum antimicrobial skin healing cream needs to be applied 2 mm beyond the periphery of the lesion to the center of the lesion. 
Comparator Agent  Topical luliconazole or oral itraconazole  patients will be prescribed either topical luliconazole or oral itraconazole or both as per the institution guidelines/protocol (for topical or oral or combination). For Group B, patients will be prescribed antifungals similar to Group A following the institution guidelines/protocol plus broad-spectrum antimicrobial skin healing cream. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age between 18 (Completed) and 70 yrs
Positive for KOH test
Able to comply to the prescribed therapy
Able to give informed consent 
 
ExclusionCriteria 
Details  Patient with a known history or clinical evidence of severe
cardiac, renal, or hepatic disease (in case of oral itraconazole is
prescribed)
Pregnant or lactating women (in case of oral itraconazole is
prescribed)
Treatment with any antipruritic medication including
antihistamine within previous 72 hours
Systemic antibiotics in the previous 2 weeks
Corticosteroid or immunosuppressant in the past 6 weeks
• Any investigational drug in the previous 3 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A total of 100 patients (50 per arm) with superficial fungal infections
(Tinea cruris, Tinea corporis) will be recruited together for both arms.Primary efficacy will be determined by clinical and mycological
assessment of lesion at baseline and at end of treatment (EOT) phase.
For clinical cure the following signs and symptoms will be assessed:
erythema, pruritus, and scaling. Each parameter will be measured on
4-point scale
 		 Baseline visit (Visit 1): Week 1
• Follow-up 1 (Visit 2): End of week 4
• Follow-up 2 (Visit 3): End of week 10
• Follow-up 3 (Visit 4): End of week 12 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   31/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Title A randomized, open label, prospective investigator initiated

interventional study to understand the effects of addition of broad-

spectrum antimicrobial skin healing cream (Silversol plus coconut

oil plus vitamin E plus Hyaluronic acid) as an adjuvant to an

antifungal agent in the management of superficial skin fungal

infections.

Study Description This is an investigator-initiated study. This study is based on the

hypothesis that the addition of an adjuvant antimicrobial skin

healing cream to an antifungal therapy will lead to better outcomes

in terms of better mycological cure and reduction in relapse rates

in the management of superficial skin fungal infections.

Phase of Study Post marketing investigator-initiated study (IIS)

Investigational

Products

Silversol, Coconut oil, Vitamin E, and Hyaluronic acid

combination, as an advanced patented broad spectrum

antimicrobial skin healing cream plus topical luliconazole or oral

itraconazole or both

Study population Male and female Indian population between 18 and 70 years old

clinically and mycologically diagnosed (positive KOH) to be

suffering from tinea cruris or tinea corporis.

Primary Objective To observe the effect of an addition of broad-spectrum

antimicrobial skin healing cream to antifungal therapy on clinical

and mycological cure

Secondary

Objectives

To observe effect of addition of broad-spectrum antimicrobial skin

healing cream to antifungal therapy on relapse and recurrence &

To observe tolerability of broad-spectrum antimicrobial skin

healing cream in real world.

Sample Size Total of 100 patients will be recruited (50 patients in each of the

two arms).

4 weeks

Duration of Study

drug Treatment

Duration of Follow

up

The first follow up will be at the end of 4th week (EOT). Post

treatment follow ups will be at week 10 (to check recurrence) and

at week 12 (to check relapse)

 
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