CTRI/2020/12/029449 [Registered on: 01/12/2020] Trial Registered Prospectively
Last Modified On:
15/03/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Clinical Study to Compare the Efficacy and Safety of Ozenoxacin Cream 1% w/w in patients with Secondarily Infected Traumatic Skin Lesions
Scientific Title of Study
“A Phase III, Prospective, Randomized, Double Blind, Single Dummy, Active Controlled, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Ozenoxacin Cream 1% w/w Versus Mupirocin Cream 2% w/w in the treatment of Patients with Impetigo.â€
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
PB/OZE/CT/20/001, Version No. 01 and Dated Sep 09, 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Tulika Rai
Designation
Associate Professor
Affiliation
Institute of Medical Sciences, Banaras Hindu University
Address
Department of Dermatology and Venereology, Varanasi-221005.
Varanasi UTTAR PRADESH 221005 India
Phone
9161023651
Fax
Email
raitulika@gmail.com
Details of Contact Person Scientific Query
Name
Sidharth Vasistha
Designation
Managing Partner
Affiliation
Om Sai Pharma Pack
Address
Om Sai Pharma Pack,
Plot No. 38 & 39, Sector-11,
I.I.E., SIDCUL, Haridwar-249403.
Hardwar UTTARANCHAL 249403 India
Phone
9910038888
Fax
Email
sidharth@pentagroup.in
Details of Contact Person Public Query
Name
Sidharth Vasistha
Designation
Managing Partner
Affiliation
Om Sai Pharma Pack
Address
Om Sai Pharma Pack,
Plot No. 38 & 39, Sector-11,
I.I.E., SIDCUL, Haridwar-249403.
Hardwar UTTARANCHAL 249403 India
Phone
9910038888
Fax
Email
sidharth@pentagroup.in
Source of Monetary or Material Support
Om Sai Pharma Pack,
Plot No. 38 & 39, Sector-11,
I.I.E., SIDCUL, Haridwar-249403,
Uttarakhand, India.
Department of Dermatology, Government of West Bengal,
108, Chittranjan Avenue, Calcutta-700073. Kolkata WEST BENGAL
8240862831
drjayantabarua@gmail.com
Dr Montu Deka
Down Town Hospital
Department of Dermatology,
Dispur, G.S. Road,
Guwahati-781006. Kamrup ASSAM
9435033901
drmontu_deka@yahoo.com
Dr Gurram Narsimha Rao Netha
Gandhi Hospital
Department of Dermatology, Venereology and Leprosy (DVL), 5th Floor, Gandhi Hospital, Musheerabad, Secunderabad-500003. Hyderabad TELANGANA
9390032196
gnrnetha@gmail.com
Dr S Nageswaramma
Government General Hospital
Department of DVL,
Opp. Railway Station, Guntur-522001. Guntur ANDHRA PRADESH
9849143461
ravindranag1960@gmail.com
Dr V Revathi
Government Medical College & Government General Hospital (Old RIMSGGH)
Department of Dermatology, Srikakulam-532001. Srikakulam ANDHRA PRADESH
8942279033
drrevathivggh@gmail.com
Dr Kranti Chandan Jaykar
Indira Gandhi Institute of Medical Sciences (IGIMS)
Department of Skin and VD, Sheikhpura, Patna-800014. Patna BIHAR
8969953194
drkcjaykar@yahoo.co.in
Dr Tulika Rai
Institute of Medical Sciences, Banaras Hindu University,
Department of Dermatology and Venereology, Varanasi-221005. Varanasi UTTAR PRADESH
9161023651
raitulika@gmail.com
Dr Konakanchi Venkatachalam
King George Hospital
Department of Dermatology,
Maharanipeta, Visakhapatnim-530002. Visakhapatnam ANDHRA PRADESH
9848398923
drkvchalam99@yahoo.com
Dr Bindiya Bansal
Maharaja Agrasen Superspeciality Hospital
Department of Dermatology,
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039. Jaipur RAJASTHAN
9765018595
bindubansal06@gmail.com
Dr Raja Bhattacharya
Medical College and Hospital
Department of Medicine,
Medical College and Hospital, Kolkata,MCH Building,
4th Floor, 88 College Street, Kolkata-700073. Kolkata WEST BENGAL
9477305539
rbrbhattacharya@gmail.com
Dr Avdhut Bhalchandra Deshpande
Prakash Institute of Medical Sciences & Research, Urun-Islampur (PIMS&R)
Department of Clinical Research,
Islampur-Sangali Road, Islampur, Tal-Walwa, Dist-Sangali, Maharashtra-415409. Sangli MAHARASHTRA
7775014777
prakashmc.research@gmail.com
Dr Anuja A Shirke
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College
Department of Dermatology,
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital,
Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002. Kolhapur MAHARASHTRA
8999524341
rcsmgmc.research@gmail.com
Dr Sunil Kumar Prabhu B
Redkar Hospital and Research Centre
Department of Dermatology,
CROM Clinical Research & Medical Tourism Pvt. Ltd.,
Mumbai-Goa Highway, Oshalbag, Village-Dhargal, Tal-Pernem-403513. North Goa GOA
Prakash Medical College Institutional Ethics Committee
Approved
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2)
Approved
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L010||Impetigo,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Mupirocin Cream 2% w/w
Patient will be provided with three tubes of Mupirocin Cream 2% w/w for first 5 days and 1 tube of Mupirocin Cream 2% w/w for next 5 days.
First 5 days - Apply a thin layer of cream topically to the affected area thrice daily (1st tube of Mupirocin Cream 2% w/w - Morning, 2nd tube of Mupirocin Cream 2% w/w - Afternoon & 3rd tube of Mupirocin Cream 2% w/w - Evening).
Next 5 days - Apply a thin layer of cream topically to the affected area thrice daily (Mupirocin Cream 2% w/w - Morning, Afternoon & Evening).
Intervention
Ozenoxacin Cream 1% w/w
Patient will be provided with 2 tubes of Ozenoxacin Cream 1% w/w & 1 tube of Placebo Cream for first 5 days and 1 tube of Placebo Cream for next 5 days.
First 5 days - Apply a thin layer of cream topically to the affected area thrice daily (Ozenoxacin Cream 1% w/w - Morning, Placebo Cream - Afternoon & Ozenoxacin Cream 1% w//w - Evening).
Next 5 days - Apply a thin layer of cream topically to the affected area thrice daily (Placebo Cream - Morning, Afternoon & Evening).
Inclusion Criteria
Age From
2.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1. Male and female patients at least 2 years of age.
2. Patients with clinical diagnosis of bullous or non-bullous impetigo. The patient was required to have a total affected area comprised between 1 to 100 cm2 with surrounding erythema not exceeding more than 2 cm from the edge of any affected area. In case of multiple affected areas, the total area was sum of each affected area and was not to exceed 100 cm2. Additionally, for patients less than 12 years, the total area was not to exceed a maximum of 2% of the body surface area.
3. Patients with total skin infection rating scale (SIRS) score of at least 3, including pus/exudate score of at least 1.
4. Written informed consent from the patient, legally acceptable representative or parent and able to follow study procedures.
ExclusionCriteria
Details
1. Patients with known or suspected hypersensitivity to quinolones or Mupirocin.
2. Female Patients who are pregnant or lactating or planning to become pregnant during the study period.
3. Females of child bearing potential who are not ready to use acceptable contraceptive methods during the course of study.
4. Patients who have an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection.
5. Patients who have a bacterial infection which, in the opinion of investigator, could not be appropriately treated by a topical antibiotic.
6. Patients who have systemic signs and symptoms of infection (e.g., a fever; defined as an axillary temperature over 37.2 oC (99.0 oF).
7. Patients with documented or suspected bacteraemia.
8. Treatment with the following anti-infective agents prior to study drug administration: oral antibiotic within 7 days; topical antibiotic (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)), within 7 days; a long-acting injectable antibiotic within 30 days.
9. Patients who have applied any topical therapeutic agent (including, but not limited to, glucocorticoid steroids) directly to the impetigo lesions within 24 hours before entry into the study.
10. Patients who have applied any topical (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)) treatment with antiseptics (e.g., Alcohol, Chlorhexidine, Hydrogen peroxide or Iodine) or other treatment that in the investigator’s opinion could confound the evaluation of the treatment effect on the investigational area(s) within 8 hours before study start or planned treatment during the study.
11. Patients who have taken any systemic or topical (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)) treatment with analgesics, anti-inflammatory or antihistaminic within 8 hours before entry into the study.
12. Patients who are taking daily dose of >15 mg of systemic prednisone or equivalent for >10 days within the period starting 14 days prior to study drug administration or anticipated through the study period.
13. Patients with known human immunodeficiency virus (HIV) infection or evidence of clinically significant immunosuppression.
14. Patients with known history of type 1 and type 2 diabetes mellitus.
15. Patients who have participated in any clinical trial in the past 3 months.
16. Patients with underlying condition and/or disease that, according to the judgment of the Investigator, would likely to interfere with completion of the course of the study drug therapy or follow-up.
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
Clinical response at the end of the study (Visit 4).
Day 11-12
Secondary Outcome
Outcome
TimePoints
Clinical response at Visit 2 and Visit 3.
Day 3-4 and Day 6-7
The difference from baseline (Visit 1) in SIRS scores at Visit 2, Visit 3 and Visit 4.
Day 1, Day 3-4, Day 6-7 and Day 11-12
Size of the affected area at Visit 2, Visit 3 and Visit 4 as compared to baseline (Visit 1).
Day 1, Day 3-4, Day 6-7 and Day 11-12
Microbiological response (microbiological success or microbiological failure) at Visit 2, Visit 3 and Visit 4.
Day 3-4, Day 6-7 and Day 11-12
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "204" Final Enrollment numbers achieved (India)="204"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
is aphase III, prospective, randomized,
double blind, single dummy, active controlled, comparative, parallel group,
multicenter clinical study to evaluate the efficacy and safety of Ozenoxacin
Cream 1% w/w versus Mupirocin Cream 2% w/w in the treatment of patients with
impetigo.
After confirming
the inclusion/exclusion criteria the patient will be randomized and provided
with study medication at screening/baseline/randomization visit (Visit 1). Patients
will be provided with diary at screening/baseline/randomization visit (Visit 1),
which needs to be brought along with in each subsequent visit till the last
visit (Visit 4). Follow up visits will be done on Day 3-4 (Visit 2), Day 6-7
(Visit 3) and Day 11-12 (Visit 4/End of the study) of treatment to assess efficacy
and safety.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent Form on the day of screening / baseline / randomization visit
(Visit 1). During this screening period, patients who are willing to give
consent will be evaluated for all the eligibility criteria. Eligible patients
aged at least 2 years fulfilling all inclusion criteria and none of the
exclusion criteria will be considered for the study.
Patients
will be assigned to either of the two arms i.e. Arm A or Arm B consisting of Ozenoxacin
Cream 1% w/w or Mupirocin Cream 2% w/w. Patients will be given the study
medication for 10 days.