| CTRI Number |
CTRI/2009/091/001025 [Registered on: 14/12/2009] |
| Last Modified On: |
22/11/2018 |
| 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 Tinea pedis and Tinea cruris. Clinical trial is to study efficacy, safety and tolerability of Naftifine Hydrochloride 1% cream in comparison to Terbinafine Hydrochloride 1% 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 Naftifine Hydrochloride 1% cream Vs. Terbinafine Hydrochloride 1% cream in patients with Tinea pedis and Tinea cruris. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| AJ/SC/13/2009 |
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 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
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 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
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 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
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 Limited |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Udayashankar |
Aarupadai Veedu Medical College & Hospital |
Asst Professor, Dept of Dermatology,Kirumampakkam-607402
Pondicherry
PONDICHERRY |
09944122744
udayadarma@yahoo.com |
| Dr U R Dhanalaxmi |
Bharathi Rajaa Speciality Hospital & Research Centre |
20, G.N Chetty Road,T Nagar-600 017
Chennai
TAMIL NADU |
044 24340642/2430693
drrdhana@yahoo.co.in |
| Dr. Prashant Palwade |
Keshav Skin and Hair Clinic |
Mahesh Nagar,Near Kabra Hospital, off Jalna Road-431002
Aurangabad
BIHAR |
0 9323707031
prashantpalwade@gmail.com |
| Dr. Sonali Kantak |
Sai Lee Hospital |
Prathamesh Horizon, Near New MHB Colony,Link Road, Boriwali (W)-
Mumbai
MAHARASHTRA |
0 9820417067
sonalikantak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| A V M College, Kirumampakkam-607402, Pondicherry, India. |
Approved |
| Bharathi Rajaa Speciality Hospital & Research Centre, G.N Chetty Road,T Nagar 600 017, Chennai, TAMILNADU |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, Tinea pedis and Tinea cruris infection, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Naftifine Hydrochloride 1% cream |
Twice a day, in the morning and evening for 28 days |
| Comparator Agent |
Terbinafine Hydrochloride 1% cream |
Twice a day, in the morning and evening for 28 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and female patients with age 18 to 70 years.
2. Clinical diagnosis of Tinea pedis and Tinea cruris confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test).
3. Written informed consent by patient.
4. Patient willing to follow up.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing females.
2. Patients suffering from onchomycosis, candidiasis, pityriasis versicolor or tinea capitis.
3. Patients with severe chronic diseases.
4. Hypersensitivity to components of Niftifine such as benzyl alcohol,cetyl alcohol ,cetyl esters wax,isopropyl myristate,polysorbat 60,sodium hydroxide,sorbitan monostearate etc.
5. 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 |
| Itching, Erythema, Scaling/Crusting, Vesicles and papules |
Day 0, Day 7,Day 14 and Day 28. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Patients and physicians Global Assessment of treatment efficacy and tolerability |
Day 28 |
| Overall response by mycological assessment (KOH mount) |
Day 0 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)
|
04/01/2010 |
| 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="3"
Days="5" |
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 comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Naftifine Hydrochloride 1% cream Vs Terbinafine Hydrochloride 1% cream (Reference Drug), in 200 patients with Tinea pedis and Tinea cruris. Date of enrollment is 04 Jan 2010.
The primary outcome measures are change in clinical efficacy parameters i.e. itching, erythema, scaling/crusting, vesicles and papules etc. by four point scales on day 0, 7, 14 and 28. Secondary out come measure is patients and physicians Global Assessment of treatment efficacy and tolerability at 28th day and overall response by mycological assessment (KOH mount) at day 0 and day 28. |