| CTRI Number |
CTRI/2010/091/000141 [Registered on: 23/02/2010] |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical Trial in-patients with Dermatomycoses.. Clinical trial is to study efficacy, safety and tolerability of Flutrimazole cream in comparison to Terbinafine Hydrochloride cream (reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flutrimazole 1% cream Vs. Terbinafine Hydrochloride 1% cream in patients with Dermatomycoses. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| AJ/SC/16/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd., Advent
43/44, ABCD, Charkop Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd,
Advent
43AB/44CD, Charkop Industrial Estate,
Kandivli (West)
Mumbai
MAHARASHTRA
400067
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Udayashankar |
Aarupadai Veedu Medical College & Hospital |
Associate Professor , Dept. of Dermatology,Kirumampakkam-607402
Pondicherry
PONDICHERRY |
09944122744
udayderm@yahoo.com |
| Dr. R. Muthukumaran |
Healthy Skin Clinic |
Saibab Colony, 174/1, ,Sri Valli Complex, N.S.R. Road, -
Coimbatore
TAMIL NADU |
099421 97800
muthu64@yahoo.com |
| Dr Prabhakar M Sangolli |
Skin Care Center |
842, 12th main, 3rd Block,Rajajinagar-560010
Bangalore
KARNATAKA |
09945684806
drlmnag2006@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC of Manipal Northside Hospital, 71 11th Main, Mafleswaram, Bangalore 560003. |
Approved |
| IEC of Pondicherry city Hospitals, Pondicherry 607 402. |
Approved |
| V.G.Medical Centre & Hospitals, 121-123, 9th Street, X-cut Road, Gandhipuram, Coimbtore 641 012 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Dermatomycoses, (1) ICD-10 Condition: B998||Other infectious disease, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Flutrimazole 1% cream |
Twice Daily for 28 Days |
| Comparator Agent |
Terbinafine Hydrochloride 1% cream |
Twice daily for 28 Days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical diagnosis of Dermatomycoses confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test).
2. Written informed consent by patient.
3. Patient willing to follow up. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing females.
2. Patients with severe chronic diseases.
3. Individuals who present a history of hypersensitivity to other antifungal imidazolic, or any of the components of the pharmaceutical form used.
4. Patients who might have required concomitant medication with other antimycotics administered by another route.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Ring-like lesion, Scaling, Erythema, Burning, Itching and Vesicles |
Day 0, Day 7, Day 14 and Day 28.
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Global Assessment of treatment |
Day 28 |
| Mycological assessment |
Day 0 and Day 28 |
| Safety and Tolerability |
Day 0, Day 7, Day 14 and Day 28. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
02/03/2010 |
| 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
Modification(s)
|
Years="0"
Months="2"
Days="24" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, comparative, double blind and multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flutrimazole 1% cream Vs Terbinafine Hydrochloride cream for 28 days in 200 patients with Dermatomycoses that will be conducted in three centers. Date of first enrollment will be 2 March, 2010.
The primary outcome measures will be assessment by grading Ring-like lesion, Scaling, Erythema, Burning, Itching and Vesicles at day 0, Day 7, Day 14 and Day 28. Mycological assessment, Global assessment of treatment and safety and tolerability will be done as secondary outcome measures. |