Effect of Mupirocin ointment in bacterial skin infections

Phase 2

Completed

• Conditions: Health Condition 1: L029- Cutaneous abscess, furuncle and carbuncle, unspecifiedHealth Condition 2: L010- ImpetigoHealth Condition 3: L088- Other specified local infections of the skin and subcutaneous tissue

• Registration Number: CTRI/2022/02/040436
• Lead Sponsor: Apex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-30
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified