NCT01112371已完成4 期
A Prospective, Single-center, Randomized, Parallel Group Trial to Investigate the Efficacy of Contractubex® Gel, Containing Extractum Cepae, Allantoin, and Heparin, in Scars After Abdominal Caesarean Section
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].
研究概览
简要总结
The purpose of this study is to investigate the efficacy of Contractubex® Gel, containing extractum cepae, allantoin and heparin, in the treatment of scars after abdominal Caesarean section compared to untreated scars after abdominal Caesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females having given birth via elective abdominal Caesarean section for the first time within the last 5 to 10 days who had their suture removed (removed at screening).
- •Age: 18 years or older.
- •The subject must be willing and must be able to complete the entire course of the trial and to comply with the trial instructions.
- •Written informed consent has been obtained from the subject.
- •Females using suitable contraceptions.
排除标准
- •Use of any inadmissible medication, e.g. systemic corticosteroids, systemic immunosuppressants (such as cytostatics, therapy with antibodies, biologics, interferone, mykophenolatmofetil, methotrexate, cyclosporine, azathioprine). Any additional topical treatment in the area of the lower abdomen, regardless of the mode of action.
- •Any other planned topical treatment in the lower part of the abdomen during the course of the trial.
- •Any infection or wound in the area to treat.
- •History of keloids or hypertrophic scars.
- •Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection.
- •Any tumor diseases in the abdominal region independent of their dignity.
- •Females having given birth via emergency abdominal Caesarean section.
- •Psychiatric problems which, in the investigator's opinion, are severe enough to interfere with the trial results.
- •Participation in another clinical trial within 30 days prior to screening.
- •Evidence or suspicion that the subject might not comply with the study directives and/or that she is not reliable or trustworthy.
- •Evidence or suspicion that the subject is not willing or unable to understand the information given to her as part of the informed consent, in particular regarding the risks and discomfort to which she would agree to be exposed.
- •Previous participation in this clinical study.
- •Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
- •Subjects who are imprisoned or are lawfully kept in an institution.
- •Employees or direct relatives of an employee of the CRO, the study center or Merz Pharmaceuticals.
研究组 & 干预措施
Contractubex
Experimental
干预措施: Contractubex (Drug)
结局指标
主要结局
Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].
时间窗: Screening and 12 weeks
The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively.
次要结局
- Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].(Screening and 6 weeks)
研究者
研究点 (1)
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