| CTRI Number |
CTRI/2025/11/096824 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF ADDING LULICONAZOLE 1% CREAM TO SYSTEMIC ANTIFUNGAL FOR GLABROUS TINEA |
|
Scientific Title of Study
|
EFFECT OF ADDING LULICONAZOLE 1% CREAM TO SYSTEMIC ANTIFUNGAL FOR GLABROUS TINEA |
| 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 SHARDA LONGANI |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
RML hospital |
| Address |
1st Floor, OPD BUILDING,RML HOSPITAL,NEW DELHI
Central
DELHI
110001
India |
| Phone |
9810526236 |
| Fax |
|
| Email |
shardalongani21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHARDA LONGANI |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
RML hospital |
| Address |
1st Floor, OPD BUILDING,RML HOSPITAL,NEW DELHI
Central
DELHI
110001
India |
| Phone |
9810526236 |
| Fax |
|
| Email |
shardalongani21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHARDA LONGANI |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
RML hospital |
| Address |
1st Floor, OPD BUILDING,RML HOSPITAL,NEW DELHI
Central
DELHI
110001
India |
| Phone |
9810526236 |
| Fax |
|
| Email |
shardalongani21@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
RML Hospital |
| 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 SHARDA LONGANI |
RML Hospital Delhi |
1st FLOOR OPD BUILDING RML HOSPITAL NEW DELHI
Central
DELHI |
09810526236
shardalongani21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee ABVIMS DR RML Hospital new delhi |
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 |
luliconazole 1percent cream |
topical application of luliconazole to systemic antifungal for glabrous tinea |
| Comparator Agent |
Terbinafine tablet 250mg BD |
Adding topical to systemic therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Extent of disease involving less than 10 percentage of body surface area.
Those with positive KOH at first assessment.
Those who have not taken any systemic antifungal in preceeding 4weeks and any topical antifungal or topical steroid in preceeding 2weeks.
willing to be part of trial. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females.
Those recieving systemic drugs with major pharmacokinetic interactions with Terbinafine.
Patients with systemic comorbidities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate cure rates with Luliconazole 1%cream and systemic antifungal drug, versus only systemic antifungal drug in patients of glabrous tinea. |
To evaluate cure rates with Luliconazole 1%cream and systemic antifungal drug, versus only systemic antifungal drug in patients of glabrous tinea. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate cost effectiveness of treatment of both groups.
To evaluate the duration of treatment of both groups.
To assess relapse rate after complete cure of both groups. |
|
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
13/11/2025 |
| 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
|
Written informed consent will be taken in Hindi or English, as per the patient’s choice. 2. Diagnosis will be made clinically and confirmed by direct microscopic examination using 10% potassium hydroxide (KOH)mount performed in clinic. 3. Recording of lesions and BSA estimation will be done and clinical photographs will be taken. 4. Patients will be asked to score their pruritus on a Numeric Rating Scale(NRS) from 0(minimum) to 10(maximum). 5. A detailed history of disease onset , duration, course, family history, and previous treatments will be recorded. Systemic antihistaminic drugs will be given to both the groups for pruritus. 7. The included patients shall be randomized to one of the two groups by a computer generated randomization chart. Patients will be given Lulicoanzole 1%cream along with T. Terbinafine 250mg BD and only T. Terbinafine 250mg BD on the basis of Randomisation chart. 8. Clinical assessment at baseline and follow ups will be performed 2 weekly.. 9. This will include recording clinical clearance(as percentage improvement), NRS score and any adverse effects , and a KOH examination from remaining lesions. 10. The end point of treatment in each recruited patient would be a complete cure or failure. 11. Relapse rates will be assessed after 12 weeks of complete cure.12. Decoding of treatment groups would be done on trial completion |