CTRI/2020/08/027198 [Registered on: 18/08/2020] Trial Registered Prospectively
Last Modified On:
27/12/2022
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
Compare the Efficacy and Safety of Mupirocin Cream USP, 2% in patients with Secondarily Infected Traumatic Skin Lesions
Scientific Title of Study
A Randomized, Double-blind, Multicenter, Three-arm, Active and Placebo-controlled, Parallel Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Mupirocin Cream USP, 2% (Cadila Healthcare Ltd, India) to Mupirocin Cream USP, 2% (Glenmark Pharmaceuticals Inc., USA) in Subjects with Secondarily Infected Traumatic Skin Lesions
Unique Hospital- Multispeciality & Research Institute
Approved
Yash Society,s Sujata Birla Hospital, Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Mupirocin Cream USP, 2% of Glenmark Pharmaceuticals Inc.
Subjects or guardian will be instructed to apply a small amount of IP topically with a cotton swab or gauze pad, to the affected area 3 times each day for 10 consecutive days from Day 1 as per randomization schedule.
Intervention
Mupirocin Cream USP, 2% of Cadila Healthcare Limited
Subjects or guardian will be instructed to apply a small amount of IP topically with a cotton swab or gauze pad, to the affected area 3 times each day for 10 consecutive days from Day 1 as per randomization schedule.
Inclusion Criteria
Age From
18.00 Month(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Healthy male or non pregnant or non lactating female aged ≥ 18 months with a secondarily infected traumatic skin lesion(s) such as a laceration, sutured wound or abrasion. The laceration or sutured wound should not exceed 10 cm in length with surrounding erythema not more than 2 cm from the edge of the lesion. An abrasion should not exceed 100 cm2 in total area with surrounding erythema not more than 2 cm from the edge of the abrasion.
2. Positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
3. Positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
4. SIRS total score for the secondarily infected traumatic skin lesion of at least 8 at baseline as per Appendix I.
5. For women of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study.
6. Subjects and/ or parent/ legal guardian must provide written informed consent or subject must provide assent, as applicable.
7. Subjects and/ or parent/ legal guardian must be willing and able to understand and comply with the requirements of the study.
ExclusionCriteria
Details
1. Subjects who are pregnant, breast feeding, or planning a pregnancy within the study participation period.
2. Subjects with any dermatological disorder that may interfere with the evaluation of his/her secondarily infected traumatic skin lesion(s), e.g., acute or chronic dermatitis involving affected area.
3. Subjects with a bacterial skin infection which, due to depth of severity, could not be appropriately treated by a topical antibiotic (e.g., severe cellulitis, abscess, ulcers, furunculosis).
4. Subjects who have secondarily infected animal/human or insect bite or puncture wound.
5. Subjects with systemic sign and symptoms of infection (i.e., fever defined as an oral temperature greater than 101ºF or 38.3ºC).
6. Subjects who require surgical intervention for treatment of the infection.
7. Subjects who have used systemic (e.g., oral or injectable) antibiotic or systemic corticosteroid (intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study) within 1 week prior to baseline.
8. Subjects who have used topical corticosteroid, topical antibiotic, or antifungal within 48 hours prior to baseline.
9. Subjects with primary or secondary immunodeficiency.
10. Subjects with diabetes.
11. Subjects who have history of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.
12. Evidence of recent alcohol or drug abuse.
13. Subjects who have been treated with an investigational drug or device within 30 days prior to study entry.
14. Subjects who have been previously enrolled in this study.
15. Institutionalized subjects.
16. Live in the same household as currently enrolled subjects.
17. Subjects with presence of any other medical condition that might adversely impact the safety of the study participants or confound the study results.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. Proportion of subjects with clinical cure at end of study.
Clinical cure is defined as subjects with skin infection rating scale (SIRS) score of 0 for all signs and symptoms on a 4-point scale.
Visit-4 (Day 17 ± 4)
Secondary Outcome
Outcome
TimePoints
1. Proportion of subjects with clinical cure at end of treatment.
2. Proportion of subjects with bacteriological cure at end of treatment.
Bacteriological cure is defined as elimination of Staphylococcus aureus and Streptococcus pyogenes or response is such that no culture material is available and therefore evidence of pathogen eradication.
3. Proportion of subjects with bacteriological cure at end of study.
1. & 2. : Visit-3 (Day 10 ± 2)
3. Visit-4 (Day 17 ± 4)
Target Sample Size
Total Sample Size="1239" Sample Size from India="1239" Final Enrollment numbers achieved (Total)= "956" Final Enrollment numbers achieved (India)="956"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a Randomized,
Double-blind, Multicenter, Three-arm, Active and Placebo-controlled, Parallel
Study in the ratio of 1:1:1 of Test product, Reference product and
Placebo.
Study objective is 1) To
evaluate bioequivalence (with clinical endpoint) of test product (Mupirocin
Cream USP, 2%of Cadila Healthcare Ltd, India) with reference product (Mupirocin
Cream USP, 2% of Glenmark Pharmaceuticals Inc., USA) in subjects with
secondarily infected traumatic skin lesions. 2) To evaluate superiority of test and reference product with placebo in
subjects with secondarily infected traumatic skin lesions. 3) To assess
safety and tolerability of study treatments.
Healthy male or non pregnant or non
lactating female aged ≥ 18 months will be considered for the study. Patient or guardian will be instructed to
apply a small amount of IP topically with a cotton swab or gauze pad, to the
affected area 3 times each day for 10 consecutive days from Day 1 as per randomization
schedule.