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.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. Proportion of patients with clinical cure at the end of treatment.
研究概览
简要总结
A total of 200 participants will be included for the study. Out of which 100 patients diagnosed with Superficial Primary Bacterial Skin Infections and 100 patients with skin ulcers of grade 1 & 2 will be
enrolled in to the study. The 100 patients will be stratified in both the groups equally(50 in each arm). The selection of the patients will be based on initial screening and study criteria. Test Arm: Mupimesh Ointment (Mupirocin 2% Ointment), apex laboratories Pvt. Ltd.,Chennai, India. and Comparator Arm: T-bact (Mupirocin 2% w/w Ointment) ointment of GSK, India. The primary and secondary outcome parameters will be assessed on respective time points and results will be analyzed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged above 12 years of age.
- •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.
- •Treatment naive, clinically diagnosed cases of uncomplicated superficial primary bacterial skin infections like Impetigo, folliculitis, furunculosis and ecthyma.
- •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.
- •Individuals who are not on treatment with any topical or systemic antiinfective/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.
排除标准
- •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.
- •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.
- •Patients with co-existing skin disorders & complicated skin ulcers (grade 3 and above)
- •Immuno-compromised individuals like known HIV positive patients.
- •Any systemic symptoms like fever, regional lymphadenopathy and cellulitis.
- •Any known cases of tuberculosis.
- •Patients of vulnerable group (lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).
- •Any history of hypersensitivity to an investigational product or compounds with similar chemical structure in the past.
- •Participation in any clinical trial in the past 1 month.
- •History of drug or alcohol abuse during the last 6 months.
结局指标
主要结局
1. Proportion of patients with clinical cure at the end of treatment.
时间窗: Day 4, 10 and 14
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.
时间窗: Day 4, 10 and 14
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.
时间窗: Day 4, 10 and 14
次要结局
- To monitor occurrence of any adverse events, throughout the entire study period.(Day 4, 10 and 14.)