| CTRI Number |
CTRI/2025/11/097925 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY ON EFFICACY, SAFETY, AND TOLERABILITY OF SALICYLIC ACID PEEL WITH ORAL ITRACONAZOLE VS ORAL ITRACONAZOLE IN THE MANAGEMENT OF TINEA CORPORIS INFECTION |
|
Scientific Title of Study
|
A PROSPECTIVE, RANDOMIZED STUDY ON EFFICACY, SAFETY, AND TOLERABILITY OF 30% SALICYLIC ACID PEEL WITH ORAL ITRACONAZOLE VS ORAL ITRACONAZOLE IN THE MANAGEMENT OF TINEA CORPORIS INFECTION |
| 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 Visheshkumar Pralhadrao Mohature |
| Designation |
Junior Resident |
| Affiliation |
Shri Bhausaheb Hire Government Medical College |
| Address |
OPD Number 18, Department of Dermatology, Venereology and Leprology, Shri Bhausaheb Hire Government Medical College, Surat Bypass Chakkarbardi, Dhule, Maharashtra- 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
9834578501 |
| Fax |
|
| Email |
visheshmohature98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Avinash Sajgane |
| Designation |
Associate Professor |
| Affiliation |
Shri Bhausaheb Hire Government Medical College |
| Address |
OPD Number 18, Department of Dermatology,Venereology and Leprology,Shri Bhausaheb Hire Government Medical College, Surat Bypass Chakkarbardi, Dhule, Maharashtra- 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
8879376867 |
| Fax |
|
| Email |
avisajgane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Visheshkumar Pralhadrao Mohature |
| Designation |
Junior Resident |
| Affiliation |
Shri Bhausaheb Hire Government Medical College |
| Address |
OPD Number 18, Department of Dermatology, Venereology and Leprology, Shri Bhausaheb Hire Government Medical College, Surat Bypass Chakkarbardi, Dhule, Maharashtra- 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
9834578501 |
| Fax |
|
| Email |
visheshmohature98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Bhausaheb Hire Government medical college and hospital, Dhule |
|
|
Primary Sponsor
|
| Name |
Dr Visheshkumar Pralhadrao Mohature |
| Address |
PG Hostel,Shri Bhausaheb Hire Government Medical College, Surat Bypass Chakkarbardi, Dhule, Maharashtra- 424001 |
| 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 Visheshkumar Pralhadrao Mohature |
Shri Bhausaheb Hire government medical college and hospital, Dhule |
OPD No 18, Department of Dermatology, Venerology and Leprosy,Shri Bhausaheb Hire government medical college and hospital,Dhule,Maharashtra
Dhule
MAHARASHTRA |
9834578501
visheshmohature98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SBHGMC, Dhule |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
30% salicylic acid peel with oral itraconazole |
30% salicylic acid peel applied locally once a week along with oral itraconazole 100 mg tablet given two times a day for 4 weeks. |
| Comparator Agent |
oral itraconazole |
oral itraconazole tablet 100 mg given two times a day for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are clinically and mycologically positive KOH mount diagnosed case of Tinea corporis.
Both sexes men and women
Age above 18 years to 60 years
Patients with less than 20 percent of body surface area involvement.
Patient who will give consent
|
|
| ExclusionCriteria |
| Details |
Patients with negative KOH mount and patients who will not give consent.
Patients having patches in more than 20 percent BSA
Age less than 18 years, Age more than 60 years,pregnancy and lactation
Patients with erosions,open wound,secondary infection,maceration at patch area
Patients with intertriginous involvement
Patients with anemia,liver diseases,kidney diseases, GI diseases
Patients with malignancy and lymphoproliferative disorders
Patients on potent immunosuppresants,biological DMARDS,organ transplant history
Patients with derranged liver and kidney profile
Patients using topical or oral antifungals within the preceding 2 weeks
Patients known allergic to salicylic acid |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical efficacy of 30% salicylic acid peel with oral Itraconazole vs oral Itraconazole in management of tinea corporis infection |
To assess the clinical efficacy of 30% salicylic acid peel with oral Itraconazole vs oral Itraconazole in management of tinea corporis infection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the safety and tolerability of 30% salicylic acid peel with oral Itraconazole vs oral Itraconazole in the management of tinea corporis infection |
3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-01-2026 and end date provided 20-09-2027?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Tinea corporis is a
common skin condition clinically presents
as erythematous or hyperpigmented plaques/patches with regular borders and
sometimes with overlying scaling.Management of tinea
corporis includes medical treatment like systemic and topical use of
antifungals.Rising cases and
recurrence with poor treatment response to antifungals highlight the need for
new therapeutic strategies.This is a
prospective, comparative, randomized clinical study to assess the efficacy, safety,
and tolerability of 30% salicylic acid peel with oral itraconazole vs oral
itraconazole in the treatment of tinea corporis infection.Each group will have 48 patients each.The study will be conducted at a tertiary hospital.One group will be treated with 30% salicylic acid peel applied locally once
a week along with oral itraconazole 100 mg tablet given two times a day for 4
weeks.The other group will be treated with with
oral itraconazole tablet 100 mg given two times a day for duration of 4 weeks.The patients will be
observed for 2 months period to assess progress, recurrence or any long-term
side effects of treatment given.Thus the study aims to find the best possible results in the management of tinea corporis infection.
|