| CTRI Number |
CTRI/2017/12/010798 [Registered on: 07/12/2017] Trial Registered Prospectively |
| Last Modified On: |
04/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Bioequivalence study with clinical end point] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check effectiveness of Clotrimazole plus Hydrocortisone cream for fungal skin infection |
|
Scientific Title of Study
|
A Double-blind, Multicentric, Randomized, Parallel Group, Comparative Bioequivalence study with Clinical end-point to evaluate the Efficacy and Safety of Fixed Dose Combination of Clotrimazole 1% w/w plus Hydrocortisone 1% w/w Cream (Test) of Encube Ethicals Pvt. Ltd., India compared with the Canesten HC Cream (Reference) of Bayer PLC, UK for the treatment of fungal skin infection with co-existing symptoms of inflammation. |
| Trial Acronym |
. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECTS/15/005, Version 02, Date: 24 may 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
410 to 412, Block "G", Titanium City Centre, Nr. Sachin Tower, 100 Ft, Road, satellite, Ahmedabad.
-
Ahmadabad
GUJARAT
380 015
India |
| Phone |
9825585119 |
| Fax |
- |
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft, Road, satellite, Ahmedabad.
-
Ahmadabad
GUJARAT
380 015
India |
| Phone |
9825585119 |
| Fax |
- |
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft, Road, satellite, Ahmedabad.
-
Ahmadabad
GUJARAT
380 015
India |
| Phone |
9825585119 |
| Fax |
- |
| Email |
milansatia@ethicare-cro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Encube Ethicals Pvt Ltd |
| Address |
Unit no. 24, Steelmade Industrial Estate, Andheri (E), Mumbai-400059 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Morningside Healthcare Ltd |
United kingdom |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shatrughan Sahay |
Ajanta Hospital and IVF Center |
Room no. 2, Hall C, No. 765, Ajanta Hospital and IVF Center, Department of Dermatology, ABC Complex, Kanpur Road, Near Krishna Cinema, Alambagh, Lucknow -226005, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
09721936101
-
archospital@yahoo.com |
| Dr Anil Gosavi |
B. J. Medical College and Sasson General Hospital |
Groundfloor, Department of skin and VD, Jai Prakash Narayan Road, Near pune railway station, Pune –411001, Maharashtra, India
Pune
MAHARASHTRA |
09665310181
--
nitin4pharma@gmail.com |
| Dr Sejal Thakkar |
GMERS Medical College and General Hospital |
Room No. 202, Dermatology OPD, Second floor, Gotri, Vadodara – 390021.
Ahmadabad
GUJARAT |
9824097310
-
drsejal98@gmail.com |
| DrMs Khemani Usha Naraindas |
Gokuldas Tejpal Hospital, Grant Government Medical College and Sir J J group of Hospitals |
1st Floor, Department of Dermatology, Gokuldas Tejpal Hospital, Near Police Commissioner office, Forte, Mumbai-400001
Mumbai
MAHARASHTRA |
9821359301
--
ushakhemani@gmail.com |
| Dr Pramod Kumar |
Kasturba Medical College and Hospital |
01 st floor, OPD no. 10, Department of Skin and STD, Attavar, Manglore – 575001, Karnataka, India
Dakshina Kannada
KARNATAKA |
9900401625
-
anupama.holla@manipal.edu |
| Dr Vipul Gupta |
KRM Hospital & Research Centre |
Room no. 04, 3/92-93, KRM Hospital and Research Centre, Dermatology department, Vijayant Khand, Gomti nagar, Lucknow-226010.
Lucknow
UTTAR PRADESH |
07007208089
-
krmhrdko@gmail.com |
| Dr Keyur Shah |
Medilink Hospital Research Center |
Room No. 101, 1st floor, Dermatology department, Basement, Medilink Hospital, Nr. Shyamal Char Rasta, 132 ft Ring Road, Satellite, Ahmedabad.
Ahmadabad
GUJARAT |
9879027136
-
drkeyurshah@yahoo.com |
| Dr Bhavik Bhavsar |
Shivam Hospital |
Department of Clinical Research, Second floor, C4, Satyanarayan Society, Gors Kuva, Jashodanagar Char Rasta, Maninagar(E).
Ahmadabad
GUJARAT |
9825953263
-
bhavik.bhavsar78@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee Manipal University |
Approved |
| IEC of B. J. government Medical College and Sasson General Hospital |
Approved |
| IEC-Ajanta Hospital and IVF Centre |
Approved |
| Institutional Ethics Committee-Grant government medical college and Sir J.J. group of Hospitals |
Approved |
| Institutional Human Ethics committee |
Approved |
| KRM Hospital Ethics Committee |
Approved |
| Medilink Ethics Committee |
Approved |
| Shivam Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Canesten HC Cream |
Topical dose do not exceed 10 mg cream per kg body weight twice daily, for a minimum of 07 days and maximum 14 days. |
| Intervention |
Clotrimazole 1% w/w plus Hydrocortisone 1% w/w Cream |
Topical dose do not exceed 10 mg cream per kg body weight twice daily, for a minimum of 07 days and maximum 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects or their legally acceptable representative who are able to provide written, signed, dated and ethics committee approved informed consent form before performing any screening procedures.
2.Male and/or female of 18-65 years (both inclusive)
3.Subjects with clinical manifestations of localized epidermal dermatophytosis and candidiasis provisionally confirmed at baseline by a microscopic examination of positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae).
4.The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity).
5.Willingness to comply with the study schedule and procedures.
|
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to clotrimazole or hydrocortisone or any of the excipients in this product.
2.Untreated bacterial skin infection such as syphilis or tuberculosis.
3.Viral skin diseases (e.g. herpes simplex, chicken pox, etc.)
4.Use of oral steroids or immunosuppressive agents within past 30 days.
5.Use of antipruritics, including antihistamines, within 772 hours prior to entry into the study.
6.Use of topical corticosteroid, antibiotic or antifungal therapy within 2 weeks prior to entry into the study.
7.Use of systemic (e.g., oral or injectable) corticosteroid, antibiotic or antifungal therapy within 1 month prior to entry into the study.
8.Use of oral terbinafine or itraconazole within 2 months prior to entry into the study.
9.Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
10.Confluent, diffuse type fungal skin infection of the entire body surface.
11.Presence of any other infection of the skin or other disease process that might confound the treatment evaluation.
12.History of dermatophyte infections unresponsive to systemic or topical antifungal drugs.
13.Subjects with history of diabetes mellitus and systemic illness.
14.Participate in any other clinical study during last 30 days.
15.Subject is a female who is pregnant or willing to get pregnant, and not ready to use contraceptive measures during the trial period or breast feeding.
16.Any other clinically significant abnormal medical condition that in the Investigators judgment would put the subject at increased risk of illness or injury, would interfere with the study participation or would interfere with the evaluation or quality of the data.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjects with mycological cure at test of cure (TOC) visit and test of sustainable cure visit. Mycological cure is defined as a negative KOH test. |
Day -5 to 0, day 14, 21, 28 plus or minus 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Reduction or absence of pruritus, erythema and scaling of infected area.
2)Total severity score no more than 2 with no individual severity score greater than 1
(3)Percentage reduction in the pruritus (itching) by VAS score.
(4)The investigator’s assessment on efficacy of the treatment based on four point Physician’s Global Assessment (PGA) will be done as follows: Poor, satisfactory, good and excellent.
|
Day -5 to 0, day 7, 14, 21, 28 plus or minus 1 |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
Final Enrollment numbers achieved (Total)= "209"
Final Enrollment numbers achieved (India)="209" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2018 |
| Date of Study Completion (India) |
19/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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)?
Response - NO
|
|
Brief Summary
|
This is a double-blind,
multicentric, randomized, parallel group, comparative bioequivalence study with
clinical end-point to evaluate the efficacy and safety of fixed dose
combination of clotrimazole 1% w/w + hydrocortisone 1 % w/w cream in
comparision with the canesten HC cream for the treatment of fungal skin
infection with co-existing symptoms of inflammation. A total of 224 male and
female subjects with who pass inclusion and exclusion criteria will be enrolled
in the study. Primary objective is to evaluate the efficacy and
secondary objective is to evaluate the safety of fixed dose combination. Visit
1 will be screening visit at day -5 to 0, visit 2 will be randomization visit
at day 1, visit 3 will be evaluation .end of therapy visit at day 7±1, visit 3
will be end of therapy visit/test of cure visit at day 14±1, visit 5 will be
test of cure visit/test of sustainable cure visit at day 21 ±1, visit 6 will be
test of sustainable cure visit at 28 ±1 day. Primary end point will be measured
by subjects with mycological cure at test of cure visit (negative KOH test) and
test of sustainable cure visit. Secondary visit will be subjective assessment,
objective assessment and physician’s global assessment. Safety assessment will
be done by measuring incidence and nature of adverse events, incidence of drug
related adverse events, changes in vital signs from baseline to end of study,
changes in haematology and biochemistry. |