| CTRI Number |
CTRI/2024/03/063613 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare effect of Luliconazole cream versus Ciclopirox olamine cream in Tinea infection |
|
Scientific Title of Study
|
"A Comparative study to evaluate the efficacy and safety of topical Luliconazole versus topical Ciclopirox olamine among patients with Tinea corporis/cruris" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen Panchaksharimath |
| Designation |
Associate professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Ground floor, Bangalore medical college and Research institute, Fort, Krishna Rajendra RD,
Bangalore
KARNATAKA
560002
India |
| Phone |
9632917662 |
| Fax |
|
| Email |
praveen.bmcri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep |
| Designation |
Junior Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Ground floor, Bangalore medical college and Research institute, Fort, Krishna Rajendra RD,
Bangalore
KARNATAKA
560002
India |
| Phone |
9980204261 |
| Fax |
|
| Email |
katakepradeep11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep |
| Designation |
Junior Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Ground floor, Bangalore medical college and Research institute, Fort, Krishna Rajendra RD,
Bangalore
KARNATAKA
560002
India |
| Phone |
9980204261 |
| Fax |
|
| Email |
katakepradeep11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Victoria Hospital, OPD Building, Krishna Rajendra Market, Bangalore urban, Bengaluru 560002 |
|
|
Primary Sponsor
|
| Name |
Pradeep |
| Address |
Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Rd, Bangalore 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 |
| DrPradeep |
Victoria Hospital |
Department of Dermatology, Victoria hospital, New OPD division,2nd floor, Bangalore-560002
Bangalore
KARNATAKA |
9980204261
katakepradeep11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute Ethics committee |
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 |
Topical Ciclopirox olamine 1% cream |
Sufficient quantity of the cream should be applied at the site of infection including 1 cm of normal skin twice daily for four weeks |
| Intervention |
Topical luliconazole 1% cream |
Sufficient quantity of the cream should be applied at the site of infection including 1 cm of normal skin twice daily for four weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients willing to give informed consent and follow up.
2)Patients of either gender aged between 18-60 years.
2)Patients with mild Tinea corporis or cruris and Positive KOH Test. |
|
| ExclusionCriteria |
| Details |
1)Patients with hypersensitivity to study medications.
2)Patients with deep fungal infections.
3)Patients with Tinea unguim, Tinea capitis and Tinea barbae.
4)Psychiatric or emotional disturbance in patients.
5)Diabetic and Immunocompromised patients. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary effectiveness is assessed based on percentage of patients achieving complete clearance. Complete clearance is defined as achieving both clinical response and mycological cure.
Clinical response is assessed using investigator global evaluation tool based on signs and symptoms which give score ranging from 1 to 5.Where score 1:Healed(absence of signs and symptoms),
score 2:markedly improved greater than 50% clinical improvement, score 3:considerable residual lesion(less than 50% clinical improvement),score 4(no change from baseline),score 5 :deterioration from baseline .Clinical response will be defined as having scores 1 or 2 (healed or markedly improved)
Mycological cure is defined by achievement of negative result on KOH mount at the end of the treatment period.
Change in Total symptom score.
|
0,2,4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety is assessed by adverse drug reactions which will be reported in CDSCO form and severity grading will be done. |
0,2,4th week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/03/2024 |
| 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)
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 - NO
|
|
Brief Summary
|
Topical antifungal drugs are commonly employed in Tinea corporis/cruris. Several tertiary centers frequently prescribe luliconazole for its broad spectrum and anti-inflammatory property. It is expensive, and relapse are documented. There is need of antifungals with diverse modes of action, as well as those that are affordable and less risk of relapse. Ciclopirox olamine inhibits enzymes necessary for fungal cellular activity. It has additional antibacterial properties which help treating superadded infections. There are very few studies comparing Luliconazole and ciclopirox olamine in the treatment of Tinea corporis/cruris in India. Hence this study is undertaken to compare Luliconazole versus ciclopirox olamine in the treatment of Tinea corporis and cruris. |