Health Condition 1: L029- Cutaneous abscess, furuncle and carbuncle, unspecified Health Condition 2: L010- Impetigo Health Condition 3: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: 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
Control Int
Sponsors
Apex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 anti infective/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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: Day 4, 10 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor occurrence of any adverse events, throughout the entire study period.Timepoint: Day 4, 10 and 14. | — |
Countries
India
Contacts
Public ContactDr Srikanth
AIIMS, Jodhpur
Outcome results
None listed