Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Mupirocin Cream USP 2% (Glasshouse): Apply topically a thin layer of small amount of cream on the affected area 3 times daily for 10 consecutive days.
Intervention2: Test product (Suppl
Sponsors
Glasshouse Pharmaceuticals Limited Canada
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or non-pregnant female aged >= 18 months till 70 years with a secondarily infected traumatic skin lesion(s) such as a laceration, sutured wound or abrasion 2. 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 3. Positive baseline culture for Staphylococcus aureus and/or Staphylococcus pyogenes from a sample taken from the secondarily infected traumatic skin lesion 4. Positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion 5. Subjects willing to give written informed consent or assent as appropriate 6. Not pregnant / not planning to be pregnant / not a lactating female. Females of childbearing potential and male subjects will be included in the study if they are willing to use an appropriate method of contraception 7. Skin Infection Rating Scale (SIRS) total score for the secondarily infected traumatic skin lesion of at least 8 at baseline
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding, or planning pregnancy 2. Any dermatological disorder that may interfere with evaluation of the subjectâ??s secondarily infected traumatic skin lesion(s), e.g., acute or chronic dermatitis involving affected area 3. 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. Secondarily infected animal/human or insect bite or puncture wound 5. Systemic sign and symptoms of infection (i.e., fever defined as an oral temperature greater than 101â?¦F or 38.3â?¦C) 6. Require surgical intervention for treatment of the infection prior to enrolment in the study 7. Subjects who have applied any topical corticosteroid, topical antibiotic, or antifungal agent for at least 48 hours (2 days) prior to baseline 8. Subjects who have been treated with a systemic antibiotic or systemic corticosteroid within 7 days prior to baseline 9. Subjects with primary or secondary immunodeficiency 10. Subjects with known history of diabetes 11. Presence of any other medical condition that might adversely impact the safety of the study participants or confound the study results 12. History of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients 13. Subjects who are alcohol or drug dependent i.e. substance of abuse 14. Treatment with an investigational drug or device within 30 days prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects in each treatment group with clinical cure, (defined as a Skin Infection Rating Scale (SIRS) score of 0 for all signs and symptoms) at Visit 4/Follow-upTimepoint: 7 days after the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects in each treatment group- with clinical cureTimepoint: Day1,Day4, Day 7 and Day 17;The proportion of subjects in each treatment group with bacteriological cure (defined as elimination of Staphylococcus aureus and Staphylococcus pyogenes or response was such that no culture material was available and therefore evidence of pathogen eradication)Timepoint: At the end of treatment visit and follow-up visit | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed