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CTRI Number  CTRI/2025/07/092054 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy and safety of Tazarotene 0.1% cream with Salicylic acid 12% ointment in fissured feet: A comparative prospective study 
Scientific Title of Study   Efficacy and safety of Tazarotene 0.1% cream versus Salicylic acid 12% ointment in fissured feet: 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  Priyanshi Tyagi 
Designation  Post graduate resident 
Affiliation  Kalinga Institute of Medical Sciences  
Address  QC 17 near KP 23,Sishu Vihar, Bhubaneswar

Nayagarh
ORISSA
751024
India 
Phone  8860665495  
Fax    
Email  tyagipriyanshi300@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Laxman Besra 
Designation  Associate Professor  
Affiliation  Kalinga Institute of Medical Sciences  
Address  KIMS Hospital , Kushabhadra Campus, 5, KIIT Rd, Bhubaneswar

Nayagarh
ORISSA
751024
India 
Phone  9500282040  
Fax    
Email  laxman.derm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priyanshi Tyagi 
Designation  Post graduate resident 
Affiliation  Kalinga Institute of Medical Sciences  
Address  QC 17 near KP 23,Sishu Vihar, Bhubaneswar

Nayagarh
ORISSA
751024
India 
Phone  8860665495  
Fax    
Email  tyagipriyanshi300@gmail.com  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, KIMS Hospital, Campus 5, KIIT , Patia , Bhubaneshwar , Odisa 751024  
 
Primary Sponsor  
Name  Kalinga Institute of Medical Sciences  
Address  Kalinga Institute of Medical Sciences, KIMS Hospital , Campus 5 , KIIT road , Bhubaneshwar 751024 
Type of Sponsor  Research institution and hospital 
 
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 Priyanshi Tyagi  Kalinga Institute of Medical Sciences  Dermatology department, KIMS Hospital, Campus 5 , KIIT road, Bhubaneshwar, Odisha
Nayagarh
ORISSA 
8860665495

tyagipriyanshi300@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Kalinga Institute ofMedical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  R23.4 Changes in skin texture - fissured feet 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Salicylic Acid 12% ointment   To be applied locally once daily at bedtime over affected area for total duration of 3 months, with follow ups once monthly 
Intervention  Tazarotene 0.1% cream   To be applied locally once daily at bedtime over affected area for total duration of 3 months, with follow ups once monthly 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All patients willing to give consent

2.Untreated fissuring of feet or xerosis  
 
ExclusionCriteria 
Details  1.Pregnant and lactating females

2.Non consenting participants

3.Immunocompromised patients

4.Skin disorders affecting the foot such as infections, dermatitis, psoriasis, un-healed skin wounds, ulcers or blisters.

5.Any participant with a known systematic disease including peripheral vascular disease or musculoskeletal disorders of the foot or ankle, rheumatoid arthritis will be excluded 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Topical tazarotene 0.1% cream has equivalent efficacy in treatment of fissured feet in comparison to salicylic acid 12% ointment  Follow up will be done every month. Final assessment will be done after 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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)   10/08/2025 
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="2"
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  

Fissured feet, a common yet neglected dermatosis, cause significant morbidity due to pain, cracking, and potential secondary infections. While keratolytic agents like salicylic acid are commonly used, treatment remains inconsistent in efficacy. Tazarotene 0.1% cream, a third-generation topical retinoid approved for psoriasis, has demonstrated keratinocyte-modulating and anti-inflammatory properties, making it a potential novel agent for managing fissured feet. However, its use in this indication is largely unexplored.

This randomized, interventional, prospective study aims to compare the efficacy and safety of topical tazarotene 0.1% cream versus salicylic acid 12% ointment in the treatment of fissured feet. A total of 80 patients (40 per group) attending the dermatology outpatient department at Kalinga Institute of Medical Sciences will be enrolled between March 2024 and March 2026. Participants will be randomly assigned to two groups: Group A will receive tazarotene 0.1% cream and Group B will receive salicylic acid 12% ointment, both applied once daily for 90 days, alongside a bland emollient.

Outcomes will be assessed through clinical scoring, photographic documentation, and symptom relief at 30-day intervals. Primary endpoints include reduction in fissure depth, pain, and callus formation; secondary endpoints include adverse effects and patient compliance.

The study addresses an important therapeutic gap in managing heel fissures, especially in the Indian context where socio-cultural factors exacerbate the condition. Findings may offer dermatologists an evidence-based, steroid-sparing alternative with better cosmetic outcomes

 
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