| CTRI Number |
CTRI/2025/07/091728 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study looks at whether adding salicylic acid to anti fungal cream work better for treating ring worm than using anti fungal cream alone |
|
Scientific Title of Study
|
A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF 30% SALICYLIC ACID PEEL WITH TOPICAL LULICONAZOLE 1% CREAM VERSUS TOPICAL LULICONAZOLE 1% CREAM ALONE FOR THE TREATMENT OF CHRONIC TINEA CORPORIS. |
| 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 Fathima Beevi |
| Designation |
Post graduate |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Room no 208, department of dermatology, Victoria hospital,KR road, fort, Kalasipalya, Bangalore, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9562662192 |
| Fax |
|
| Email |
fathimabeevi103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa k |
| Designation |
Head of the department |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Room no 208, department of dermatology, Victoria hospital, KR road, fort, Kalasipalya, Bangalore, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
shilpakvinod1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fathima Beevi |
| Designation |
Post graduate |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Room no 208, department of dermatology, Victoria hospital, KR road, fort, Kalasipalya, Bangalore, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9562662192 |
| Fax |
|
| Email |
fathimabeevi103@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr FATHIMA BEEVI
POSTGRADUATE, DEPARTMENT OF DERMATOLOGY, VICTORIA HOSPITAL, ROOM NO 208, kr road forte, Karnataka ,India, PIN code : 560002 |
|
|
Primary Sponsor
|
| Name |
Dr Fathima beevi |
| Address |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, FORT, KR ROAD, KALASIPALYA, BENGALURU KARNATAKA, PIN CODE- 560002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Fathima Beevi |
Victoria hospital |
Room no 208, Department of dermatology, Victoria hospital,KR road, fort, Kalasipalya, Bangalore, Karnataka, PIN code - 560002
Bangalore
KARNATAKA |
09562662192
fathimabeevi103@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of BMCRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Luliconazole 1% cream |
Applied twice daily by the participant |
| Intervention |
Salicylic acid peel 30% plus luliconazole 1% cream |
Salicylic acid peel 30% applied once weekly by the investigator plus luliconazole 1% cream twice daily applied by the participant |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give consent
Age group between 19-60 years
Chronic tinea corporis (more than 6 months)
KOH positive
|
|
| ExclusionCriteria |
| Details |
Patients not willing to give informed consent.
Patients less than 18 years of age.
Pregnancy and lactation.
Patients with KOH mount negative.
Patients with more than 10% body surface area involvement.
Tinea faciei
Tinea cruris
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in pruritis, erythema and scaling
KOH mount negative.
|
Baseline, 3 weeks, 6 weeks |
|
|
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 3 |
|
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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The financial burden of treating superficial dermatophytoses particularly in cases of extensive disease is often substantial and frequently incurred out-of-pocket by patients at all stages of treatment. The widespread use of ineffective and sometimes hazardous fixed drug combinations has contributed to the near-epidemic prevalence of superficial fungal infections. This in turn has led to chronic and treatment-resistant tinea infections. The present study aims to evaluate the efficacy of 30% salicylic acid in the management of tinea infection and its impact on duration of treatment. |