| CTRI Number |
CTRI/2025/03/082290 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [topical application of 30% salicylic acid] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study on fugal disease between conventional treatment and a new treatment of approach using 30 percent salicylic acid peel in patient with fungal disease |
|
Scientific Title of Study
|
ASSESSING THE EFFICACY OF 30 PERCENT SALICYLIC ACID PEEL WITH
1 PERCENT TOPICAL LULICONAZOLE FOR TREATMENT OF DERMATOPHYTOSIS A
RANDOMISED CONTROL TRIAL IN CHENGALPATTU TAMilNADU INDIA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sivaram M |
| Designation |
First year residency, dermatology postgraduate |
| Affiliation |
karpaga vinayaga institute of medical sciences and research institute |
| Address |
department of dermatology karpaga vinayaga institute of medical sciences and research institute ,
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
6382779140 |
| Fax |
|
| Email |
hardeepsinghnijar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
drdhanalakshmi |
| Designation |
head of the department |
| Affiliation |
karpaga vinayaga institute of medical sciences and research institute |
| Address |
department of dermatology , karpaga vinayaga institute of medical sciences and research institute
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9566120848 |
| Fax |
|
| Email |
drdhanuk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sivaram M |
| Designation |
First year residency, dermatology postgraduate |
| Affiliation |
karpaga vinayaga institute of medical sciences and research institute |
| Address |
department of dermatology ,karpaga vinayaga institute of medical sciences and research institute ,
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
6382779140 |
| Fax |
|
| Email |
hardeepsinghnijar@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR Sivaram , department of dermatology ,karpaga vinayaga institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
dr sivaram |
| Address |
boys hostel A- 75 , karpaga vinayaga institute of medical sciences , gst road ,chinakolambakkam, mamandur , chengalpattu - 603308 |
| 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 |
| sivaram M |
karpaga vinayaga institute of research institute |
department of dermatology , room no 29
Kancheepuram
TAMIL NADU |
06382779140
hardeepsinghnijar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee of karpaga vinayaga institute of medical sciences and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional antifungal treatment |
oral itraconazole with topical antifungal (luliconazole agent)
per oral as per standard drug dosage for the weight ,
weekly once for 6 weeks
per oral ,
topical - local application
1% luliconazole 1 gram daily for 6 weeks |
| Intervention |
KERATOLYTICS APPLICATION |
30% salicylic acid application along with oral itraconazole
local application , 0.5ml of 30percent salicylic acid application
2-3minutes for every 2weeks for total of 6 week duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient aged above 18 years of age
patient clinically diagnosed with dermatophytosis
patient mycologically confirmed tinea by KOH mount |
|
| ExclusionCriteria |
| Details |
pregnant , lactation women
individuals with extensive tinea corporis involving a large area of the body ( more than 10% of body surface area |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
mycological cure : absence of fungal hyphae on KOH mount
clinical cure : complete resolution of all the clinical symptoms ( itching , scaling , erythema ) |
it is assessed at baseline, week 4 , week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
clinical cure : complete resolution of all the clinical symptoms ( itching , scaling , erythema )
adverse effects : measure the ocuurance of any side effects
quality of life : assessed by DQLI questionaire |
it is assessed in baseline , week 4 , week 8 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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 - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - it is available in the publication journal
- For how long will this data be available start date provided 12-06-2024 and end date provided 02-05-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dermatophytosis are superficial fungal infections by three species of fungi Microsporum, Trichophyton, Epidermophyton. Diagnosis is usually based on history and clinical appearance plus direct microscopy of a potassium hydroxide(KOH) preparation. Culture or histologic examination is rarely required for diagnosis. In India the disease burden of dermatophytosis ranges from 36.6 % to 78.4 % (Shaikh Naseem et al.,2023) Most anti fungal drugs target ergosterol which is unique to the fungal cell wall and absent in mammalian cells. A single molecule alters target by natural selection ,Irrational use of combination of anti-fungal drugs with topical steroid usage causes increased in resistance for anti fungal treatments ,Finding the most effective and readily accessible approach remains crucial. Salicylic acid is a member of group of compound known as beta hydroxy acids, It is a keratolytic agent, Which desquamates stratum corneum along with keratinophyllic dermatophytes which resides there. The azole group of anti fungal medication have been extensively employed for treatment of dermatophytosis, The major challenges and problem in dermatophytosis treatment will be anti fungal resistant. The study has the potential to provide valuable insight to overcome the problem of topical antifungal resistance by replacing with 30% salicylic acid for the treatment of dermatophytosis, Application of 30% salicylic acid in Dermatology OPD twice a week will help to overcome the patient’s non-compliance and inconsistent application of anti fungal, thus improving the adherence of patient towards treatment Comparing the efficacy and safety of 30% salicylic acid with Topical luliconazole as an adjuvant therapy in achieving mycological and clinical cure. Primary outcome variable 1) Mycological cure : Absence of fungal hyphae on KOH Mount when visualise under microscope 2) Clinical cure : Complete resolution of all the clinical symptoms (itching, scaling, erythema, no new lesions ) Secondary outcome variable 1) Adverse effects : Measures the occurrence of any side-effects with the treatment 2) Quality of life : Assessed by DLQI questionnaire Patient attending dermatology OPD in Karpaga Vinayaka Institute of medical sciences and research Centre, Of either gender and above 18 years of age. Clinically diagnosed with dermatophytosis, Relevant history will be taken regarding age, sex, duration of complaints, treatment history, comorbidities and family history. Patient with KOH mount positive are enrolled in this study ,Patient were randomly allocated into two groups by chit method (simple block computerised randomisation), Two groups- group A and group B are divided , Group A will be given topical luliconazole with oral itraconazole. Group B will be given 30% salicylic acid with oral itraconazole. Follow-up for once every two weeks for eight weeks . 30% salicylic acid will be given at week 0, week 2, week 4 , week 6 for Group B. The KOH Mount is performed at baseline , fourth week ,eighth weeks of treatment. Dermatology life quality index questionnaire and Total symptom score will be assessed at baseline, four and eighth weeks of treatment. Consent will be taken from the patient for using information
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