| CTRI Number |
CTRI/2024/04/065336 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How effective and safe is Naftifine 2% compared to Luliconazole 1% for treating Ringworm skin infection at a tertiary care hospital |
|
Scientific Title of Study
|
Efficacy and Safety of the Topical Naftifine 2% Therapy versus Topical Luliconazole 1% Therapy in Patients with Localized Tinea Corporis in a Tertiary Care Centre |
| 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 R SUGANYA |
| Designation |
MD |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF PHARMACOLOGY
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, GST ROAD, PALAYANOOR, MADURANTHAKAM,TAMIL NADU
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8344179459 |
| Fax |
|
| Email |
suganyaraj3196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANU SAIN |
| Designation |
MD |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, GST ROAD, PALAYANOOR, MADURANTHAKAM,TAMIL NADU
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8754428258 |
| Fax |
|
| Email |
drsanusain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR R SUGANYA |
| Designation |
MD |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF PHARMACOLOGY
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, GST ROAD, PALAYANOOR, MADURANTHAKAM,TAMIL NADU
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8344179459 |
| Fax |
|
| Email |
suganyaraj3196@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.R.SUGANYA
DEPARTMENT OF PHARMACOLOGY
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
CHENGALPATTU
TAMIL NADU |
|
|
Primary Sponsor
|
| Name |
DR R SUGANYA |
| Address |
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE GST ROAD CHINNA KOLAMBAKKAM PALAYANOOR TAMIL NADU 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 |
| DR SUGANYA R |
Karpaga Vinayaga Institute of Medical Sciences and research centre |
Department of Dermatology
Room number 27
chinnakolambakkam
Madurantahkam
Chengalpattu
Kancheepuram
TAMIL NADU |
8344179459
suganyaraj3196@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE HUMAN STUDIES |
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 |
| Comparator Agent |
Topical Luliconazole 1% cream |
Mild to moderate lesions of Localized Tinea Corporis patients every 2 weeks single application each day for a total of 6 weeks |
| Intervention |
Topical Naftifine 2% cream |
Mild to moderate lesions of Localized Tinea Corporis patients every 2 weeks single application each day for a total of 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients above the age of 18 years of either sex who were clinically and mycologically diagnosed of a case of localized dermatophytosis were included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with extensive dermatophytosis, other forms of tinea infections
Superadded bacterial infection
Immunocompromised patients
Dermatitis such as contact dermatitis, atopic dermatitis, psoriasis, other skin diseases
Use of corticosteroids in the last 4 weeks.
Pregnant and lactating mothers
Patients with a history of hypersensitivity to azole antifungals
Patients who received topical antifungal within 1 week before baseline visit and patients who received systemic antifungals within 4 weeks before baseline were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome was to determine the efficacy and safety of two topical {naftifine, luliconazole} therapies in terms of a number of patients achieving complete clearance. |
The primary outcome was to determine the efficacy and safety of two topical {naftifine, luliconazole} therapies in terms of a number of patients achieving complete clearance at 2 weeks, 4 weeks, 6 weeks , 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome was to determine the safety of two topical {naftifine, luliconazole} therapies in terms of number of patients achieving complete clearance. |
The secondary outcome was to determine the safety of two topical {naftifine, luliconazole} therapies in terms of number of patients achieving complete clearance at 2 weeks, 4 weeks, 6 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
A total of 60 patients with Localized Tinea Corporis in a tertiary care centre each arm comprising of 30 patients will be recruited based on clinical and mycological reports after getting CTRI registration number. the patients are given treatment after proper informed consent for about 6 weeks by recording improvements every 2 weeks and then follow up done every 2 weeks for about 6 weeks. Total duration of the study will be 6 months. in case of emergency or adverse reactions following treatment they will be treated accordingly ater given information to IEC committee. The improvement of symptoms will be noted and statistical analysis will be done accordingly. |