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CTRI Number  CTRI/2024/08/072543 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 24/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of the Efficacy and Safety of two treatment modalities for Pitted Keratolysis with Five Percent Benzoyl Peroxide Versus Fusidic Acid  
Scientific Title of Study   Study of the Efficacy and Safety of Five Percent Benzoyl Peroxide Versus Fusidic Acid in the Treatment of Pitted Keratolysis A Randomised Controlled Trial 
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 Namrata Sandeep Kenkre 
Designation  Junior Resident 
Affiliation  Sri Devaraj Urs Medical College 
Address  Room Number 26, Department of Dermatology, RL Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  7798610289  
Fax    
Email  nkenkre89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajashekar T S 
Designation  Professor and HOD 
Affiliation  Sri Devaraj Urs Medical College 
Address  Room Number 26, Department of Dermatology, RL Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  9448316136  
Fax    
Email  rajashekardermat@sduaher.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Namrata Sandeep Kenkre 
Designation  Junior Resident 
Affiliation  Sri Devaraj Urs Medical College 
Address  Room Number 26, Department of Dermatology, RL Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563103
India 
Phone  7798610289  
Fax    
Email  nkenkre89@gmail.com  
 
Source of Monetary or Material Support  
RL Jalappa Hospital,Sri Devaraj Urs Medical College, Tamaka , Kolar, India 563103 
 
Primary Sponsor  
Name  Dr Namrata Sandeep Kenkre 
Address  Room Number 26, Department of Dermatology, RL Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar , India 563103 
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 Namrata Sandeep Kenkre  RL Jalappa Hospital, Sri Devaraj Urs Medical College  Room Number 26, Department of Dermatology, Sri Devaraj Urs Medical College, Tamaka, Kolar India 563101
Kolar
KARNATAKA 		 7798610289

nkenkre89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Devaraj Urs Medical College Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  5% Benzoyl Peroxide Gel  Daily 2 times Local Application of 5% Benzoyl Peroxide Gel(Morning and Night),2 Times Follow up for Every 2 Weeks ( Week 2, Week 4) with a Duration of Treatment of 4 weeks. 
Comparator Agent  Fusidic Acid  Daily 2 times Local Application of Fusidic Acid (Morning and Night),2 Times Follow up for Every 2 Weeks ( Week 2, Week 4) with a Duration of Treatment of 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Newly diagnosed pitted keratolysis 
 
ExclusionCriteria 
Details  1.Patients on antiperspirants ( such as aluminium chloride, aluminium zirconium and aluminium chlorohydrate)
2.Patients with hypersensitivity to drugs (topical fusidic acid and benzoyl peroxide)
3.Patients on topical sulfone products (e.g., dapsone)
4.Patients on topical hydroquinone.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Measurement of efficacy of modalities on the basis of visual analogue scale.
2.Measurement of safety of modalities on the basis of visual discomfort scale.
 		 Treatment for a period of 4 weeks and patient is then followed up at week 2 and week 4 after treatment commencement 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects post treatment with 5% benzoyl peroxide and fusidic acid in treatment of pitted keratolysis  every 2 weeks follow up for a treatment period of 4 weeks 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/08/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Pitted keratolysis is a common infective skin disease caused by gram-positive bacteria affecting the soles of feet. Fusidic Acid is one antibiotic that is a frequently applied topically to treat infections of the skin and soft tissues. It is one of the mainstay treatments in Pitted Keratolysis. Benzoyl peroxide having antimicrobial as well as keratolytic properties is being used for the treatment for acne vulgaris and is one of the newer treatment modalities for Pitted Keratolysis. This Study is undertaken to Determine the Efficacy and Safety of 5% Benzoyl Peroxide Versus Fusidic Acid in the Treatment of Pitted Keratolysis. 
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