| CTRI Number |
CTRI/2019/05/019449 [Registered on: 30/05/2019] Trial Registered Prospectively |
| Last Modified On: |
24/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
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Type of Study
|
Real world study |
| Study Design |
Single Arm Study |
|
Public Title of Study
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An observational study to assess the usefulness of Eberconazole cream (Ebernet®) in patients with tinea (fungal) infection |
|
Scientific Title of Study
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A prospective, real world, observational study to evaluate the effectiveness and safety of Eberconazole 1% cream (Ebernet®) in Indian patients with Tinea corporis and Tinea cruris |
| Trial Acronym |
NA |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GGI-EBERNET-09-2018 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Partha Chatterjee |
| Designation |
Head Clinical Research and CTSM |
| Affiliation |
SIRO Clinpharm pvt Ltd |
| Address |
Kalpataru Prime, 1st Floor, Unit no. 3 and 4, Plot no. D-3, Road no.16, Wagle Industrial Estate, Thane(West)- 400604,Maharashtra India
Thane
MAHARASHTRA
400604
India |
| Phone |
022-61088000 |
| Fax |
022-6108-8081 |
| Email |
partha.chatterjee@siroclinpharm.com |
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Details of Contact Person
Public Query
|
| Name |
Partha Chatterjee |
| Designation |
Head Clinical Research and CTSM |
| Affiliation |
SIRO Clinpharm pvt Ltd |
| Address |
Kalpataru Prime, 1st Floor, Unit no. 3 and 4, Plot no. D-3, Road no.16, Wagle Industrial Estate, Thane(West)- 400604,Maharashtra India
MAHARASHTRA
400604
India |
| Phone |
022-61088000 |
| Fax |
022-6108-8081 |
| Email |
partha.chatterjee@siroclinpharm.com |
|
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Source of Monetary or Material Support
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| Dr. Reddy’s Laboratories Ltd.
8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana – 500034. India |
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Primary Sponsor
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| Name |
Dr Reddys Laboratories Ltd |
| Address |
8 2 337 Road No 3 Banjara Hills Hyderabad Telangana 500034 India |
| Type of Sponsor |
Other [Primary] |
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Details of Secondary Sponsor
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| Name |
Address |
| Siro Clinpharm Pvt Ltd |
Kalpataru Prime, 1st Floor, Unit no. 3 and 4, Plot no. D-3, Road no.16, Wagle Industrial Estate, Thane(West)- 400604,Maharashtra India |
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Countries of Recruitment
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India |
Sites of Study
Modification(s)
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| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Ghate |
Dr Ghates Skin Hair and Laser center |
Dr Ghates Skin hair and Laser center 301 Business Point D K sandu road Chembur Mumbai-400071
Mumbai
MAHARASHTRA |
9869032470
sdghate_2000@yahoo.com |
| Dr Manas Chatterjee |
INHS Asvini Hospital |
Department of Dermatology,
Near RC Church Colaba Mumbai Maharashtra- 400005
Mumbai
MAHARASHTRA |
8697709387
drmanaschatterjee@gmail.com |
| Dr Siddhartha Das |
Ramakrishna Mission Seva Pratishthan Vivekananda Institute of Medical Sciences |
Skin OPD-Room No 8 Dermatology Department 99 Sarat Bose Road Kolkata 700 026
Kolkata
WEST BENGAL |
91-9433044590
siddharthadasin@yahoo.co.in |
| Dr Jayakar Thomas |
Skin Care Centre |
Vasanth Apartment, No 110, M.S.Koil Street, Royapuram, Chennai – 600 013
Chennai
TAMIL NADU |
9841038484
jayakarthomas@gmail.com |
| Dr Sharad Teltumde |
Sparsh Skin And Dental Clinic |
Chandresh Gaurav C/4 Near Vasai Janta Bank Nallasopara West Dist Palghar- 401203
Mumbai (Suburban)
MAHARASHTRA |
9975299425
drsharadht@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Adroit Ethics committee, Navi Mumbai |
Approved |
| Adroit Ethics committee, Navi Mumbai |
Approved |
| Adroit Ethics committee, Navi Mumbai |
Approved |
| Institutional Ethics Committee, RMSP, VIMS, Kolkata |
Approved |
| Universal Ethics Committee, Independent Ethics Committee, Chennai |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
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Intervention / Comparator Agent
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Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex, greater than and equal to 18 years of age
2. Patients prescribed eberconazole 1% cream for topical treatment of tinea cruris and tinea corporis by the treating physician.
3. Patients willing to give written informed consent for study participation. |
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| ExclusionCriteria |
| Details |
1. Patients requiring systemic anti-fungal drugs for management of their condition.
2. Pregnant and lactating women.
3. Patients with any significant medical illness that would prevent study participation, at investigator’s discretion. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
EFFECTIVENESS EVALUATION
Proportion of patients with improvement of signs and symptoms from baseline to 2 weeks of treatment with eberconazole 1% cream |
Baseline and 2 weeks |
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Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
EFFECTIVENESS EVALUATION
1. Proportion of patients with improvement of signs and symptoms from baseline to 1 week and 3 weeks of treatment with eberconazole 1% cream.
2. Percent change in signs and symptom score from baseline to 1, 2, and 3 weeks of treatment with eberconazole 1% cream.
|
Baseline, 1 week, 2 weeks and 3 weeks |
Efficacy EVALUATION
3. Physician’s global assessment of effectiveness and safety at 1st, 2nd and 3rd week of treatment with eberconazole 1% cream.
4. Patient’s assessment of effectiveness and acceptability at 1st, 2nd and 3rd weeks of treatment with eberconazole 1% cream.
SAFETY EVALUATION
1. Safety will be assessed based on the spontaneous AE reports generated by the patients/clinician and will be reported as per as per marketed product guidelines |
Baseline, 1 week, 2 weeks and 3 weeks |
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Target Sample Size
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Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
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Phase of Trial
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N/A |
Date of First Enrollment (India)
Modification(s)
|
11/06/2019 |
| Date of Study Completion (India) |
13/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The data has been Published in December 2020, in Journal Named International Journal of Research in Dermatology.
Article titled: Effectiveness and safety of eberconazole 1% cream in Indian patients with Tinea corporis and Tinea cruris: a prospective real-world study |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Tinea corporis and tinea cruris are the major superficial dermatophyte infections caused by Trichophyton species which invade the keratinized tissues such as skin, hair, and nail to cause an infection. Most tinea corporis and tinea cruris infections are treated with topical agents. Various topical antifungal agents are currently employed for the management of tinea corporis and tinea cruris as once or twice daily application for 2–4 weeks.
Eberconazole is one such topical antifungal agent approved for the treatment of cutaneous dermatophyte (cutaneous mycosis) infections. Although Ebernet® has been studied extensively in clinical trials, there is lack of data on efficacy and safety outcomes of Ebernet® in real world clinical setting, especially in Indian patients. Therefore, current study has been planned to evaluate the effectiveness and safety of Ebernet® in real-world clinical setting in India.
This is a prospective, observational study to collect data on the effectiveness and safety of eberconazole 1% cream in patients with tinea corporis and tinea cruris, in real world clinical setting. This study will include up to 300 Indian patients’ data recruited within 3 months from up to 10 centres, diagnosed with localized tinea cruris and tinea corporis and prescribed eberconazole 1% cream as topical treatment, by the treating physician. The overall observation period will be 21 days±3 days, and data collection for the study will conclude with final patient visit.
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