| CTRI Number |
CTRI/2012/08/002914 [Registered on: 24/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
20/04/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between Whitfields ointment + Oral fluconazole Vs 1% butenafine in tinea infections of skin |
|
Scientific Title of Study
|
A comparative study to evaluate efficacy, safety and cost effectiveness between Whitfield’s ointment + oral Fluconazole vs topical 1% Butenafine in tinea infections of skin |
| 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 Saket J Thaker |
| Designation |
Senior Resident |
| Affiliation |
NIL |
| Address |
Department of Clinical Pharmacology Seth G.S. Medical College and KEM Hospital Parel Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
09820599985 |
| Fax |
|
| Email |
saketthaker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dimple S Mehta |
| Designation |
Professor and Head |
| Affiliation |
NIL |
| Address |
Department of Pharmacology C U Shah Medical College Surendranagar
Surendranagar
GUJARAT
363001
India |
| Phone |
09375060963 |
| Fax |
|
| Email |
drdimplesmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saket J Thaker |
| Designation |
Senior Resident |
| Affiliation |
|
| Address |
Department of Clinical Pharmacology Seth G.S. Medical College and KEM Hospital Parel Mumbai
Mumbai (Suburban)
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 |
Dudhrej road, Surendranagar -363001 Gujarat |
| 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 Pharmacology and Dermatology |
C.U. Shah Medical College
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 |
To be applied twice a day for four weeks. |
| Intervention |
Whitfields Ointment + Oral Fluconazole vs 1% Butenafine |
Whitfields ointment to be applied twice a day. Oral fluconazole (150 mg)to be taken once aweek for four weeks |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
New patients attending skin O.P.D. |
|
| ExclusionCriteria |
| Details |
1) Follow up cases
2) pregnant or lactating women,
3) patients having allergy to topical imidazole or any other antifungals used in the study
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in baseline sign and symptoms score
2. Change in Physician’s Global Evaluation Response
b. Safety (No. of ADRs developed & percentage of the participants developing ADRs)
c. Cost effectiveness (Incremental cost and Incremental effectiveness)
|
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of clinico mycological correlation
2. Comparison of relapse rate with both the treatments
3. To identify and find the prevalence of different species of tinea
|
one month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/05/2009 |
| 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
|
Yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is a randomized, open label parallel
group, trial comparing the efficacy, safety and cost effectiveness between
Whitfield’s ointment + Oral Fluconazole vs. 1% butenafine in tinea infections
of skin. The primary outcome measures were the efficacy a. Efficacy (1. Change
in baseline sign and symptoms score 2. Change in Physician’s Global Evaluation
Response b. Safety (No. of ADRs developed & percentage of the participants
developing ADRs) c. Cost effectiveness (Incremental cost and Incremental
effectiveness) over one month. The secondary outcomes were1) Assessment of
clinico mycological correlation2)Comparison of relapse rate with both the
treatments 3)To identify and find the prevalence of different species of tinea |