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CTRI Number  CTRI/2025/07/090662 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Whitfield’s Ointment and Luliconazole Cream vs. Luliconazole Alone for Treating Ringworm (Tinea Corporis): A Randomized Study 
Scientific Title of Study   Efficacy of Whitfield’s Ointment (3% Salicylic acid + 6% Benzoic acid) with topical Luliconazole vs topical Luliconazole for tinea corporis: A randomized controlled study.  
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 Soham Virani 
Designation  Junior resident 
Affiliation  kalinga institute of medical sciences 
Address  KIMS hospital , campus 5 , kiit road, patia , bhubaneswar - 751024

Khordha
ORISSA
751024
India 
Phone  9167026690  
Fax    
Email  sohamvirani96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mitanjali Sethy 
Designation  Associate professor DVL 
Affiliation  kalinga institute of medical sciences 
Address  KIMS hospital campus 5 kiit road patia bhubaneswar

Khordha
ORISSA
751024
India 
Phone  8093420126  
Fax    
Email  mitanjalis444@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Soham Virani 
Designation  Junior resident 
Affiliation  kalinga institute of medical sciences 
Address  KIMS hospital ,campus 5 , kiit road , patia , bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9167026690  
Fax    
Email  sohamvirani96@gmail.com  
 
Source of Monetary or Material Support  
KIMS hospital, campus 5, kiit road , patia , bhubaneswar , odisha - 751024 
 
Primary Sponsor  
Name  Soham Virani 
Address  KIMS Hospital campus 5 kiit road patia bhubaneswar odisha 751024 
Type of Sponsor  Other [self] 
 
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 Soham Virani  Kims hospital  Dermatology opd number 14, 15 1st floor.
Khordha
ORISSA 		 9167026690

sohamvirani96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE KIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B354||Tinea corporis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  topical luliconazole 1% cream  using it twice daily for the entire diameter of the tinea lesion for a period of 1 month with follow up at 14 days each 
Intervention  Whitfields ointment( 3% Salicylic acid with 6% Benzoic acid ) with topical luliconazole 1% cream  using both topical modalities in intervention arm twice daily for the entire lesion diameter for a period of 1 month with follow up at 14 days each 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  consenting adults who are clinically diagnosed as tinea corporis
 
 
ExclusionCriteria 
Details  a. Patient with superficial dermatophytosis other than tinea corporis.
b. Extensive tinea corporis more than 20% BSA
c. Patients already on oral/topical antifungals.
d. Pregnant and lactating mothers
e. Patients on any immunosuppressant drugs/immunosuppressive patients
f. Any Seropositive patient – HIV, HbsAg , HCV , VDRL
g. Patient with history of severe allergy or anaphylaxis
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
. Whitfields ointment with Topical Luliconazole has better efficacy and better response time as compared to topical luliconazole in treatment of tinea corporis  both modalities being compared at baseline , 14 days , 28 days. 
 
Secondary Outcome  
Outcome  TimePoints 
The disease regression is faster in whitfields ointment with Topical Luliconazole as compared to topical luliconazole.  baseline 14 days & 28 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 4 
Date of First Enrollment (India)   20/07/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sohamvirani96@gmail.com].

  6. For how long will this data be available start date provided 26-01-2026 and end date provided 26-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Superficial fungal infections of the skin, hair, and nail are among the most common infective dermatoses seen in the dermatology outpatient department. Dermatophytosis refers to a superficial mycotic infection caused by either of the three groups of keratinophilic fungi, namely, Epidermophyton (skin and nails), Trichophyton (skin, nails, hair), Microsporum (skin and hair). These comprise the most common agents responsible for superficial cutaneous fungal infections.

The cases we see in all hospitals are just the tip of the iceberg in the community. Numerous treatment options are available used either as monotherapy, sequential therapy and combination therapy mainly including topical and systemic antifungal drugs.

Whitfield ointment (WO) is an antiseptic ointment that was widely used in the past to treat topical fungal infections. Its efficacy has been shown to be equal to other topical antifungal in several studies conducted. Very few studies have compared its efficacy with topical antifungals . Hence this study will compare efficacy of whitfields ointment against the  antifungal therpay being given currently in tinea corporis.

 
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