A Double Blinded Randomized, Multicentric Parallel Group Active Controlled Clinical Trial comparing the Efficacy Of Mupirocin ointment Of Apex Laboratories Pvt. Ltd With Mupirocin Ointment (T-Bact) Of GSK in the treatment Of Superficial Primary Bacterial Skin Infections.

Apex Laboratories Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•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.

•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
•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
•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.

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