| CTRI Number |
CTRI/2017/05/008687 [Registered on: 29/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of ringworm infections of skin with terbinafine |
|
Scientific Title of Study
|
Response to terbinafine in cutaneous tinea infections |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Same as above
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
05422309488 |
| Fax |
|
| Email |
sanjaye2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Same as above
UTTAR PRADESH
221005
India |
| Phone |
05422309488 |
| Fax |
|
| Email |
sanjaye2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakriti Shukla |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Same as above
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
05422309488 |
| Fax |
|
| Email |
kivi.somi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Sanjay Singh |
SS Hospital |
Room No. 207, Skin and VD OPD, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH |
05422309488
sanjaye2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tinea corporis, tinea cruris, tinea manuum, tinea pedis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Terbinafine |
1. Terbinafine dose: 5mg/kg body weight/day orally for 4 weeks
2. Patients will also apply topical Terbinafine (1%) cream twice daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with tinea corporis, tinea cruris, tinea manuum and tinea pedis who show fungal elements on KOH microscopy of skin scrapings |
|
| ExclusionCriteria |
| Details |
1. Use of terbinafine (oral or topical) in past 1 week
2. Pregnancy or lactation
3. Past history of drug reaction to terbinafine (oral or topical)
4. Concurrent hepatic or renal disease as stated by the patient
5. Inability of the patient to come for follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete clearance of lesions and negative KOH microscopy |
0, 2, 4 weeks.
Cured patients reviewed after 1 month of completion of treatment and assessed for reappearance of leions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
0 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2016 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There is a general impression among dermatologists in India that patients with tinea infections are not responding to treatment with terbinafine, which used to be a very effective drug. However, clinical data in this regard is not available. This study aims to look into the effectiveness of terbinafine in real-world situation. |