| 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
|
|
|
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
|
|
|
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 |