| CTRI Number |
CTRI/2012/06/002714 [Registered on: 05/06/2012] Trial Registered Retrospectively |
| Last Modified On: |
04/06/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between 2% Sertaconazole vs topical 1% Butenafine in tinea infections of skin |
|
Scientific Title of Study
|
A comparative study to evaluate efficacy, safety and cost effectiveness between to evaluate efficacy, safety and topical 1% Butenafine vs topical 2% Sertaconazole in tinea infections of skin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saket J Thaker |
| Designation |
Senior Resident |
| Affiliation |
NIL |
| Address |
Currently Department of Clinical pharmacology Seth GSMC and KEMH Parel Mumbai
Formerly Dept of Pharmacology C U Shah Medical college Surendranagar 363001 GUjarat
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
09820599985 |
| Fax |
|
| Email |
saketthaker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dimple S Mehta |
| Designation |
Professor and Head |
| Affiliation |
NIL |
| Address |
Department of pharmacology C U Shah Medical College Surendranagar
Surendranagar
GUJARAT
363001
India |
| Phone |
|
| Fax |
|
| Email |
drdimplesmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saket J Thaker |
| Designation |
Senior Resident |
| Affiliation |
|
| Address |
Currently Department of Clinical pharmacology Seth GSMC and KEMH Parel Mumbai
Formerly Dept of Pharmacology C U Shah Medical College Surendranagar Gujarat 363001
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09820599985 |
| Fax |
|
| Email |
saketthaker@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology and Department of Skin and VD CU Shah Medical College and Hospital |
| Address |
C U Shah medical College Dudhrej Road Surendranagar |
| Type of Sponsor |
Private 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 |
| Saket J Thaker |
Department of Skin and VD and Department of Pharmacology |
C U Shah Medical College Surendranagar
Surendranagar
GUJARAT |
09820599985
saketthaker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tinea infections of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% Butenafine |
topical antifungal agent to be applied twice a day on the lesions for four weeks. |
| Intervention |
2% Sertaconazole |
Topical antifungal agent, to be applied twice a day on the lesion for four weeks. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
New cases of tinea infections of skin from skin OPD |
|
| ExclusionCriteria |
| Details |
1) Follow up cases
2) Pregnant and Lactating women
3) patients having hypersensitivity to one of the antifungal agents used in the study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| a) Efficacy( 1. Change in baseline sign and symptom score 2. Change in Physicians Global Evaluation Response b). Safety (No. Of patients developing ADRs and type of ADRs) c). Cost effectivenes (Incremental cost and Incremental effectiveness) |
a) Efficacy( 1. Change in baseline sign and symptom score 2. Change in Physicians Global Evaluation Response b). Safety (No. Of patients developing ADRs and type of ADRs) c). Cost effectivenes (Incremental cost and Incremental effectiveness) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Clinicomycological correlation
2)Relapse rate asssessment
3)Find out the prevalent species of tinea infections |
one month |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/05/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is " A randomized open label controlled comparative trial to evaluate the efficacy, safety and cost effectiveness between 2% Sertaconazole vs 1% butenafine in tinea infections of skin." This study was conducted at C.U. Shah Medical College, Dudhrej road, Surendranagar as a part of P.G. Thesis.
|