| CTRI Number |
CTRI/2025/10/096259 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of topical Luliconazole vs topical Naftifine |
|
Scientific Title of Study
|
Comparison of Topical 2 percent Luliconazole vs Topical 2 percent Naftifine in patients of Tinea Cruris and or Tinea Corporis an Open level Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupam Roy |
| Designation |
Post Graduate Trainee |
| Affiliation |
Agartala Government Medical College and GBP Hospital |
| Address |
Agartala Government Medical College and GBP Hospital, Department of Pharmacology,
Agartala, West Tripura
West Tripura
TRIPURA
799006
India |
| Phone |
7005844072 |
| Fax |
|
| Email |
rupamroy351@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasis Ray |
| Designation |
Professor and HOD |
| Affiliation |
Agartala Government Medical College and GBP Hospital |
| Address |
Agartala Government Medical College and GBP Hospital,
Department of Pharmacology,
Agartala, West Tripura
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debasis Ray |
| Designation |
Professor and HOD |
| Affiliation |
Agartala Government Medical College and GBP Hospital |
| Address |
Agartala Government Medical College and GBP Hospital,
Department of Pharmacology,
Agartala, West Tripura
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Agartala Government Medical College and GBP Hospital,Department of Pharmacology, Agartala, West Tripura, 799006, India |
|
|
Primary Sponsor
|
| Name |
Rupam Roy |
| Address |
Agartala Government Medical College and GBP Hospital Department of Pharmacology fourth floor Agartala West tripura 799006 India |
| 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 |
| Rupam Roy |
Agartala Government Medical College and GBP Hospital |
Department of pharmacology agartala government medical college fourth floor
West Tripura
TRIPURA |
7005844072
rupamroy351@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Clinical Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Luliconazole |
Topical Luliconazole in patients of Tinea Cruris and or Tinea Corporis, Total duration of the study is one and half years |
| Comparator Agent |
Topical Naftifine |
Topical Naftifine in patients of Tinea Cruris and or Tinea Corporis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with clinical signs and symptoms consistent with Tinea Cruris and or Tinea Corporis
2.Laboratory confirmation of dermatophyte infection by positive potassium hydroxide microscopy |
|
| ExclusionCriteria |
| Details |
1.Pregnant or breastfeeding women
2.Individuals who are immunocompromised or have uncontrolled diabetes mellitus
3.Participation in another investigational drug or clinical trial within the past 30 days |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical response in the form of clinical and mycological cure by changes in erythema , scaling , pruritis in tinea corporis and /or tinea cruris after 28 days of treatment and at the end of 42 days in both groups |
Clinical response in the form of clinical and mycological cure by changes in erythema , scaling , pruritis in tinea corporis and /or tinea cruris after 28 days of treatment and at the end of 42 days in both groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Events |
4 weeks & 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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="1"
Months="6"
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
|
This study aims to compare the efficacy of topical luliconazole and topical naftifine in the treatment of patients diagnosed with tinea cruris and or tinea corporis . Diagnosis is based on clinical response and mycological cure rate. Topical naftifine and topical luliconazole are the drugs for the therapeutic option due to their efficacy , safety and minimal side effects. An open label interventional study participants included will be all the patients in the age group of 18 years or above based on predefined inclusion and exclusion criteria. Primary outcome variables are clinical response and mycological cure rate. Sample size has been calculated using N master software .The total sample size would be 130 participants. |