| CTRI Number |
CTRI/2022/02/040436 [Registered on: 18/02/2022] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Mupirocin ointment in bacterial skin infections |
|
Scientific Title of Study
|
A Double Blinded Randomized, Multicentric Parallel Group Active Controlled Clinical Trial comparing the Efficacy Of Mupirocin ointment Of Apex Laboratories Pvt. Ltd With Mupirocin Ointment (T-Bact) Of GSK in the treatment Of Superficial Primary Bacterial Skin Infections. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MUPIROCIN/010/20 Version : 1.1 Date- 29-10-2021 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shoban Babu Varthya |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room no. 264, 2nd floor, Department of Pharmacology,
AIIMS, Jodhpur
(An Institute of National Importance under
Ministry of Health and Family Welfare)
Government of India, Rajasthan, India.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8437726777 |
| Fax |
|
| Email |
drshobanpgimer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoban Babu Varthya |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room no. 264, 2nd floor, Department of Pharmacology,
AIIMS, Jodhpur
(An Institute of National Importance under
Ministry of Health and Family Welfare)
Government of India, Rajasthan, India.
RAJASTHAN
342005
India |
| Phone |
8437726777 |
| Fax |
|
| Email |
drshobanpgimer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srikanth |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Room no.203. Dept. of community medicine and family medicine,
AIIMS, JODHPUR.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9489325306 |
| Fax |
|
| Email |
srikanthlatha2003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Apex Laboratories Pvt Ltd, SIDCO Complex, Guindy, Chennai |
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Pvt Ltd |
| Address |
SIDCO Complex, Guindy, Chennai -600032 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Shoban Babu Varthya |
AIIMS, JODHPUR |
Room no. 264, 2nd floor, Department of Pharmacology, AIIMS, Jodhpur (An Institute of National Importance under Ministry of Health and Family Welfare) Government of India, Rajasthan, India.
Jodhpur
RAJASTHAN |
8437726777
drshobanpgimer@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee, Jodhpur |
Approved |
| Mahatma Gandhi Medical College & Research Institute Institutional Human Ethics Committee |
Approved |
| SRM Medical College Hospital & Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L029||Cutaneous abscess, furuncle and carbuncle, unspecified, (2) ICD-10 Condition: L010||Impetigo, (3) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mupimesh: Mupirocin 2% of apex |
Mupirocin Ointment applied twice
daily, in morning 08.00 AM and evening 08.00 PM, at the interval of every 12
hours for the period of 14 days |
| Comparator Agent |
T-Bact: Mupirocin (2% w/w ointment) of
GSK. |
Mupirocin Ointment twice
daily, in morning 08.00 AM and evening 08.00 PM, at the interval of every 12
hours for the period of 14 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged above 12 years of age.
2. Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to
participate and give written informed consent voluntarily.
3. Treatment naive, clinically diagnosed cases of uncomplicated superficial
primary bacterial skin infections like Impetigo, folliculitis, furunculosis and ecthyma.
4. Skin Infection Rating Scale (SIRS) total score for the target lesion of at least 4 with at least 3 of the five signs/symptom categories present at baseline.
5. Individuals who are not on treatment with any topical or systemic antiinfective/steroid preparation for more than two consecutive days in the past 1 week, prior to the screening visit, or any other type of topical and systemic
medications.
|
|
| ExclusionCriteria |
| Details |
1. Women of child bearing potential who are either unwilling or unable to use
an acceptable method of birth control [such as oral contraceptives, other
hormonal contraceptives (implants or injectable products, vaginal products,
skin patches), or IUDs, barrier methods] to avoid pregnancy during the study
period.
2. Patients who have Complicated bacterial skin infections such as those
requiring the systemic administration of antibiotics, i.e., those associated with
lymphadenitis, signs and symptoms of systemic toxicity, extensive skin
lesions, and localized deep infections of skin and secondary skin infections
including burns and history epilepsy and kidney disease.
3. Patients with co-existing skin disorders & complicated skin ulcers (grade 3
and above)
4. Immuno-compromised individuals like known HIV positive patients.
5. Any systemic symptoms like fever, regional lymphadenopathy and cellulitis.
6. Any known cases of tuberculosis.
7. Patients of vulnerable group (lactating mother, elderly >80 years,
handicapped, seriously ill, mentally challenged).
8. Any history of hypersensitivity to an investigational product or compounds
with similar chemical structure in the past.
9. Participation in any clinical trial in the past 1 month.
10. History of drug or alcohol abuse during the last 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients with clinical cure at the end of treatment.
2. To assess the mean change in the grading (scoring system) of the bacterial skin infection on 4th, 8th and 14th day after topical treatment with the study drug.
3. Subjective evaluation of the bacterial skin infection by the physician and the patient on 4th, 8th and 14th day after topical treatment with the study drug.
|
Day 4, 10 and 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor occurrence of any adverse events, throughout the entire study period. |
Day 4, 10 and 14. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2022 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A total of 200 participants will be included for the study. Out of which 100 patients diagnosed with Superficial Primary Bacterial Skin Infections and 100 patients with skin ulcers of grade 1 & 2 will be enrolled in to the study. The 100 patients will be stratified in both the groups equally(50 in each arm). The selection of the patients will be based on initial screening and study criteria. Test Arm: Mupimesh Ointment (Mupirocin 2% Ointment), apex laboratories Pvt. Ltd.,Chennai, India. and Comparator Arm: T-bact (Mupirocin 2% w/w Ointment) ointment of GSK, India. The primary and secondary outcome parameters will be assessed on respective time points and results will be analyzed statistically. |