FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101218 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 14/01/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Other (Specify) [Anti bacterial]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the Role of a Healing Cream in Faster Recovery from Fungal Skin Infections 
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 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr D revathi 
Designation  Director and chief consultant dermatologist  
Affiliation  Revathi Hospital 
Address  Department of Dermatology, Revathi Hospital,12 Vidyalaya Road Near Ramakrishna Park, Salem
Department of Dermatology, Revathi Hospital,12, Vidyalaya Road, Near Ramakrishna Park, Salem
Salem
TAMIL NADU
636007
India 
Phone  9487541982  
Fax    
Email  revathi.derma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr D revathi 
Designation  Director and chief consultant dermatologist  
Affiliation  Revathi Hospital 
Address  Department of Dermatology, Revathi Hospital,12 Vidyalaya Road Near Ramakrishna Park, Salem
Department of Dermatology, Revathi Hospital,12, Vidyalaya Road, Near Ramakrishna Park, Salem
Salem
TAMIL NADU
636007
India 
Phone  9487541982  
Fax    
Email  revathi.derma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr D revathi 
Designation  Director and chief consultant dermatologist  
Affiliation  Revathi Hospital 
Address  Department of Dermatology, Revathi Hospital,12 Vidyalaya Road Near Ramakrishna Park, Salem
Department of Dermatology, Revathi Hospital,12, Vidyalaya Road, Near Ramakrishna Park, Salem
Salem
TAMIL NADU
636007
India 
Phone  9487541982  
Fax    
Email  revathi.derma@gmail.com  
 
Source of Monetary or Material Support  
Docmode Health Technologies Ltd kalaptra building ,Malad West, Mumbai, 4600064 
 
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 revathi  Dr Revathi Hospitals  Revathi Hospital, Department of Dermatology Room 1 12, Vidyalaya road, Near Ramakrishna Park,
Salem
TAMIL NADU 
94875 41982

revathi.derma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kirupananda Variyar medical college and hospitals  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 
Comparator Agent  oral fluconazole and topical antifungal  For group A, patients will be prescribed oral fluconazole (10mg/kg/day) (maximum daily dose 400mg/day) or oral fluconazole plus topical antifungal (luliconazole or oxiconazole) as per the institution guidelines/protocol (for topical or oral or combination).10 weeks of treatment 
Intervention  Silversol plus coconut oil plus vitamin E plus Hyaluronic acid) as an adjuvant to an antifungal agent   adjuvant to an antifungal agent in the managem skin fungal infections.Like topical antifungal, broad-spectrum antimicrobial skin healing cream needs to be applied 2 periphery of the lesion to the center of the lesion. 10 Weeks of treatment  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age between 18 (Completed) and 70 yrs
2.Positive for KOH test
3.Able to comply to the prescribed therapy
4.Able to give informed consent 
 
ExclusionCriteria 
Details  1. Patient with a known history or clinical evidence of severe
cardiac, renal, or hepatic disease (in case of oral antifungal is
prescribed)
2. Pregnant women (in case of oral fluconazole)
3. Systemic antibiotic use in previous 2 days
4. Corticosteroid or immunosuppressant in the past 6 weeks
• Any investigational drug in the previous 3 months 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe the effect of addition of broad-spectrum antimicrobial
skin healing cream to antifungal therapy on clinical and mycological cure. Total of 100 patients will be recruited (50 patients in each of the
two arms).
10 weeks 
To observe the effect of addition of broad-spectrum antimicrobial
skin healing cream to antifungal therapy on clinical and mycological cure. Total of 100 patients will be recruited (50 patients in each of the
two arms).
10 weeks 
 
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)   28/01/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

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.Physicians are finding it difficult to manage fungal infections. They are trying all available antifungals in their arsenal with all possible

combinations. Sometimes an oral antifungal is tried with two

different topicals while other times two orals are tried with one

topical. Despite these efforts controlling fungal epidemic seems

challenging. Although new antifungals are the need of an hour

bringing new molecules to market is daunting and time-consuming

affair. Given this scenario, optimizing the use of available antifungal

agents becomes very important.Broad-spectrum antimicrobial skin healing cream has metallic silver

nanoparticles in the form of Silversol which can offer antimicrobial

action and thereby help in optimizing the use of available antifungal

agents. Apart from that it has coconut oil and hyaluronic acid which

can help maintain skin moisturization, and Vitamin E which can

fight oxidative stress associated with fungal infection.

Thus, this study aims to find out whether adding broad-spectrum

antimicrobial skin healing cream to standard antifungal therapy can

lead to better outcomes in the real world.To understand the clinical and mycological implications of adding a

broad-spectrum antimicrobial skin healing cream to antifungal

therapy for the management of superficial skin fungal infections.For clinical cure the following signs and symptoms will be assessed:

erythema, pruritus, and scaling. Each parameter will be measured on

4-point scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe).

The investigator will assess [Physician Global Assessment (PGA)]

these parameters for all 5 visits.

For mycological cure, KOH testing will be done at baseline and at the

end of the treatment (EOT) i.e. at the end of 10 weeks.

Clinical and mycological cure rates will be compared in two arms.

Secondary outcomes:

Secondary efficacy will be determined by presence of recurrence {re-

occurrence of a lesion within few weeks (<6 weeks) after completion of

treatment} or relapse {Occurrence of lesion after a longer infection

free period (6 to 8 weeks) in a patient who has been cured clinically}

post completion of treatment by observing clinical signs and

symptoms for fungal infection.

Rate of recurrence or relapse in both groups will be compared.

For tolerability assessment, adverse effect/s will be monitored and

documented (if any), and will be compared in both groups at the EOT.A total of 100 patients (50 per arm) with superficial fungal infections

(Tinea infections) will be recruited together for both arms.This will be an investigator initiated interventional, controlled study.

 
Close