CTRI/2020/08/027198已完成未知
A Randomized, Double-blind, Multicenter, Three-arm, Active and Placebo-controlled, Parallel Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Mupirocin Cream USP, 2% (Cadila Healthcare Ltd, India) to Mupirocin Cream USP, 2% (Glenmark Pharmaceuticals Inc., USA) in Subjects with Secondarily Infected Traumatic Skin Lesions - NA
Ms Cadila Healthcare Limited0 个研究点目标入组 956 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 956
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Healthy male or non pregnant or non lactating female aged >= 18 months with a secondarily infected traumatic skin lesion(s) such as a laceration, sutured wound or abrasion. 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.
- •2. Positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
- •3. Positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
- •4. SIRS total score for the secondarily infected traumatic skin lesion of at least 8 at baseline as per Appendix I.
- •5. For women of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study.
- •6. Subjects and/ or parent/ legal guardian must provide written informed consent or subject must provide assent, as applicable.
- •7. Subjects and/ or parent/ legal guardian must be willing and able to understand and comply with the requirements of the study.
排除标准
- •1. Subjects who are pregnant, breast feeding, or planning a pregnancy within the study participation period.
- •2. Subjects with any dermatological disorder that may interfere with the evaluation of his/her secondarily infected traumatic skin lesion(s), e.g., acute or chronic dermatitis involving affected area.
- •3. Subjects with a 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. Subjects who have secondarily infected animal/human or insect bite or puncture wound.
- •5. Subjects with systemic sign and symptoms of infection (i.e., fever defined as an oral temperature greater than 101ºF or 38.3ºC).
- •6. Subjects who require surgical intervention for treatment of the infection.
- •7. Subjects who have used systemic (e.g., oral or injectable) antibiotic or systemic corticosteroid (intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study) within 1 week prior to baseline.
- •8. Subjects who have used topical corticosteroid, topical antibiotic, or antifungal within 48 hours prior to baseline.
- •9. Subjects with primary or secondary immunodeficiency.
- •10. Subjects with diabetes.
- •11. Subjects who have history of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.
- •12. Evidence of recent alcohol or drug abuse.
- •13. Subjects who have been treated with an investigational drug or device within 30 days prior to study entry.
- •14. Subjects who have been previously enrolled in this study.
- •15. Institutionalized subjects.
- •16. Live in the same household as currently enrolled subjects.
- •17. Subjects with presence of any other medical condition that might adversely impact the safety of the study participants or confound the study results.
研究者
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