Compare the Efficacy and Safety of Mupirocin Cream USP, 2% in patients with Secondarily Infected Traumatic Skin Lesions

Completed

• Conditions: Disorder of the skin and subcutaneous tissue, unspecified,

• Registration Number: CTRI/2020/08/027198
• Lead Sponsor: Ms Cadila Healthcare Limited

Brief Summary

This is a Randomized,Double-blind, Multicenter, Three-arm, Active and Placebo-controlled, ParallelStudy in the ratio of 1:1:1 of Test product, Reference product andPlacebo.

 Study objective is 1) Toevaluate bioequivalence (with clinical endpoint) of test product (MupirocinCream USP, 2%of Cadila Healthcare Ltd, India) with reference product (MupirocinCream USP, 2% of Glenmark Pharmaceuticals Inc., USA) in subjects withsecondarily infected traumatic skin lesions. 2) To evaluate superiority of test and reference product with placebo insubjects with secondarily infected traumatic skin lesions. 3) To assesssafety and tolerability of study treatments.

 Healthy male or non pregnant or nonlactating female aged ≥ 18 months will be considered for the study. Patient or guardian will be instructed toapply a small amount of IP topically with a cotton swab or gauze pad, to theaffected area 3 times each day for 10 consecutive days from Day 1 as per randomizationschedule.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study Completion: 2022-12-12
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1239

Inclusion Criteria

• 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.
• Positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
• Positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
• SIRS total score for the secondarily infected traumatic skin lesion of at least 8 at baseline as per Appendix I.
• 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.
• Subjects and/ or parent/ legal guardian must provide written informed consent or subject must provide assent, as applicable.
• Subjects and/ or parent/ legal guardian must be willing and able to understand and comply with the requirements of the study.

Exclusion Criteria

• Subjects who are pregnant, breast feeding, or planning a pregnancy within the study participation period.
• 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.
• 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).
• Subjects who have secondarily infected animal/human or insect bite or puncture wound.
• Subjects with systemic sign and symptoms of infection (i.e., fever defined as an oral temperature greater than 101ºF or 38.3ºC).
• Subjects who require surgical intervention for treatment of the infection.
• 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.
• Subjects who have used topical corticosteroid, topical antibiotic, or antifungal within 48 hours prior to baseline.
• Subjects with primary or secondary immunodeficiency.
• Subjects with diabetes.
• Subjects who have history of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.
• Evidence of recent alcohol or drug abuse.
• Subjects who have been treated with an investigational drug or device within 30 days prior to study entry.
• Subjects who have been previously enrolled in this study.
• Institutionalized subjects.
• Live in the same household as currently enrolled subjects.
• Subjects with presence of any other medical condition that might adversely impact the safety of the study participants or confound the study results.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Proportion of subjects with clinical cure at end of study.	Visit-4 (Day 17 ± 4)
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 Measures

Name	Time	Method
1. Proportion of subjects with clinical cure at end of treatment.	2. Proportion of subjects with bacteriological cure at end of treatment.

Trial Locations

Locations (33)

Agrawal Hospital; 🇮🇳 Patan, GUJARAT, India

Aman Hospital and Research Center; 🇮🇳 Vadodara, GUJARAT, India

Anand Surgical Hospital Pvt Ltd; 🇮🇳 Ahmadabad, GUJARAT, India

Apex Superspecialty Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Belgaum Institute of Medical Sciences; 🇮🇳 Belgaum, KARNATAKA, India

Dr Jivraj Mehta Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. RML institute of medical science; 🇮🇳 Lucknow, UTTAR PRADESH, India

GMERS Medical Collage and General Hospital; 🇮🇳 Vadodara, GUJARAT, India

Government Medical College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

HB Hospital; 🇮🇳 Rudraprayag, UTTARANCHAL, India

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Agrawal Hospital

🇮🇳Patan, GUJARAT, India

Dr Amit Kumar Agrawal

Principal investigator

9825079851

dr.amitagrawal64@gmail.com