| CTRI Number |
CTRI/2018/02/011935 [Registered on: 16/02/2018] Trial Registered Prospectively |
| Last Modified On: |
23/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy of Ketoconazole in Combination With Beclomethasone |
|
Scientific Title of Study
|
An Open Label, Single arm, Observational Study to Evaluate the Efficacy, Safety & Tolerability of Ketoconazole 2 % in Combination With Beclomethasone 0.025% in Patients With Tinea and sebaceous dermatitisInfections |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr M V Hara Prasad |
| Designation |
Managing Director |
| Affiliation |
Med Manor Organics Pvt ltd |
| Address |
Med Manor Organics Pvt ltd
#16-11-477/45, Dilsukhnagar,
Hyderabad - 500 036.
Hyderabad
ANDHRA PRADESH
500 036
India |
| Phone |
9246493649 |
| Fax |
|
| Email |
babumvh2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Busetty Laxmaiah |
| Designation |
Vice president - opera |
| Affiliation |
Med Manor Organics Pvt ltd |
| Address |
Med Manor Organics Pvt ltd
#16-11-477/45, Dilsukhnagar,
Hyderabad - 500 036
Hyderabad
ANDHRA PRADESH
500036
India |
| Phone |
9440623241 |
| Fax |
|
| Email |
laxamaiah.busetty@medmanor.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Pavan Suman |
| Designation |
Executive |
| Affiliation |
Med Manor Organics Pvt ltd |
| Address |
Med Manor Organics Pvt ltd
#16-11-477/45, Dilsukhnagar,
Hyderabad - 500 036
Hyderabad
ANDHRA PRADESH
500 036
India |
| Phone |
8885886353 |
| Fax |
|
| Email |
tps@medmanor.in |
|
|
Source of Monetary or Material Support
|
| Med Manor Organics Pvt ltd
16-11-477/45, Dilsukh Nagar, Hyderabad, Telangana 500036 |
|
|
Primary Sponsor
|
| Name |
Med Manor Organics Pvt ltd |
| Address |
16-11-477/45, Dilsukh Nagar, Hyderabad, Telangana 500036 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Dr Madan Mohan NT |
Dr. B.R. Ambedkar Medical College |
First floor Department of dermatology Room no 1
Kadugondanahalli, Bengaluru, Karnataka 560045
Bangalore
KARNATAKA |
9845074316
madanmohan1869@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr B R Ambedkar Medical College and Hospital Institution Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients With Tinea Infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketoconazole 2 % in Combination With Beclomethasone 0.025% |
once daily to cover the affected and immediate surrounding area. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with tinea infections who are either treatment naive or were not on any treatment for at-least 3 months
2.Have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy
3.Subjects aged 12 to 75 years with Tinea Infections
4.Subjects with Epidermal type of Tinea infections
5.Subjects willing to return for all clinic visits and complete all study-related procedures |
|
| ExclusionCriteria |
| Details |
1.Subjects with dermal or any other type of fungal infections other than epidermal type
2.Subjects who are either pregnant or breast feeding
3.Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication
4.Subjects taking any other form of alternative treatment like ayurvedic etc.. for fungal infections
5.Subjects known to have hypersensitivity to any of the ingredients of the formulation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacyof ketoconazole 2 % in combination with Beclomethasone 0.025% ointment in preventing the Tinea Infections |
2 Weeks form base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and tolerability of ketoconazole 2 % in combinaton with Beclomethasone 0.025% cream based on the adverse effects as mentioned by the patient |
total 4 week
2 weeks study follow up
2 weeks Telephonic follow up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
19/02/2018 |
| Date of Study Completion (India) |
24/10/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 study is an Open Label, Single arm, Observational Study to Evaluate the Efficacy, Safety & Tolerability of Ketoconazole 2 % in Combination With Beclomethasone 0.025% in (Keto B ointment) Patients With Tinea Infections for evaluation of the safety, efficacy and tolerability of 4Ketoconazole 2 % in combination with Beclomethasone 0.025% in patients with Dermatophytoses (Fungal Infection) |