Randomized, double-blind, placebo-controlled, three-arm parallel design, multiple-site bioequivalence study with clinical endpoints

Phase 1/2

Completed

• Conditions: Healthy human subjects with Secondarily Infected Traumatic Skin Lesions

• Registration Number: CTRI/2019/04/018858
• Lead Sponsor: Encube Ethicals Private Limited

Brief Summary

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Mupirocin Cream USP 2%  in the Treatment of 696 Subjects with Secondarily Infected Traumatic Skin Lesions. At screening/baseline visit, subjects shall be randomly (Double’blind) assigned in 1:1:1 fashion to one of the 3 treatment groups at visit 1. A specimen for bacterial culture shall be prepared from wound pus/exudates as well as a slide shall be prepared for Wright stain/Gram stain during screening/baseline visit. A specimen for bacterial culture shall be prepared from wound pus/exudates at Visit 3 and Visit 4. Statistical comparisons shall be made between test and reference, test and placebo, and reference and placebo. The primary endpoint is the clinical response, Bacteriological response as determined at visit 4/follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-05
• Study Completion: 2020-04-02
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

• 1)Healthy male and non-pregnant female subjects 18 months of age or older with a definite clinical diagnosis of a secondarily infected traumatic skin lesion 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 or abrasion should not exceed 100 cm2 in 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)Subjects with a Skin Infection Rating Scale (SIRS) total score of at least 8 at baseline and have white blood cells observed on Wright stain or Gram stain slide prepared from wound pus/exudates.
• 4)Female Subjects of child bearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-barrier method, transdermal, injection or implants, non-hormonal or hormonal, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
• OR Postmenopausal for at least 1 year.
• OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
• Note: Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study.
• Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to the study.
• 5)Male subjects must use accepted methods of birth control including abstinence 6)Subject willing to provide written consent or assent, as appropriate.
• 7)Subjects shall be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
• 8)Subjects shall be in good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesions, that might interfere with the study evaluations.

Exclusion Criteria

• 1)Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
• 2)Subject with positive urine pregnancy test at screening.
• 3)Subjects with primary or secondary immunodeficiency.
• 4)Subjects with systemic signs or symptoms of infection.
• (i.e., fever defined as an oral temperature greater than 101ºF or 38.3ºC).
• 5)Subjects with Diabetes.
• 6)Any dermatological disorder that may interfere with the evaluation of the subject’s secondarily infected traumatic skin lesion(s), e.g., acute or chronic dermatitis involving affected area.
• 7)Subjects who require surgical intervention for treatment of infection.
• 8)Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
• 9)Subjects who have a known hypersensitivity to any of the following (in any dosage form): penicillin’s, cephalosporin’s, other beta-lactam antimicrobials or mupirocin and/or to any component of the study medications.
• 10)Subjects with a bacterial skin infection that, because of depth or severity, should not be treated with a topical antibiotic (e.g., severe cellulitis, abscess, ulcer, furunculosis).
• 11)Subjects who have a secondarily infected bite (animal, human or insect) or puncture wound.
• Note: Infections resulting from the scratching of an insect bite shall be considered secondarily infected traumatic skin lesions.
• 12)Subjects who have applied any topical therapeutic agent i.e. topical corticosteroid, topical antibiotic, or antifungal directly to the wound within 48 hours prior to study entry.
• 13)Subjects who have been treated with a systemic antibiotic or systemic corticosteroid within 7 days prior to study entry.
• 15)Subjects who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry.
• 16)Subjects who have been previously enrolled in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.SIRS – Skin Infection Rating Scale	Visit 1, 2, 3 and 4
2.Bacteriologic Culture	Visit 1, 2, 3 and 4

Secondary Outcome Measures

Name	Time	Method
Monitoring Adverse events	Visit 1, 2, 3 and 4

Trial Locations

Locations (16)

Ajanta Hospital and IVF Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

DR D Y Patil Hospital and Research centre; 🇮🇳 Mumbai, MAHARASHTRA, India

GMERS Medical College and Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Grant Government Medical College And SIR J J Group of Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

HI Tech Multi specialty hospitL; 🇮🇳 Gandhinagar, GUJARAT, India

Ishwar Institute of Health Care; 🇮🇳 Aurangabad, MAHARASHTRA, India

Kanoria Hospital and Research centre; 🇮🇳 Gandhinagar, GUJARAT, India

KRM Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lifepoint Multi specialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Lotus Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

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Ajanta Hospital and IVF Centre

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Shatrughan Sahay

Principal investigator

9721936101

drshatru@yahoo.com