EUCTR2005-004265-42-GB进行中（未招募）不适用
A double blind, placebo controlled, randomised trial to investigate the efficacy of Juvista in the improvement of scar appearance in patients undergoing bilateral reduction mammaplasty. - Juvista in breast reduction
Renovo0 个研究点目标入组 39 人开始时间: 2006年1月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Female patients, aged 18-65 with a BMI of 15-32.
- •Patients of child-bearing potential using acceptable method(s) of contraception
- •Patients with clinically acceptable laboratory results for laboratory tests specified in the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with significant breast asymmetry
- •Patients who have had previous surgery in the area to be excised within 1 year
- •Patients with a history of a bleeding disorder
- •Patients with a history of breast malignancy
- •Patient with a chronic or currently active skin disorder
- •Patients with a clinically significant medical condition that would impair healing.
- •Patients with hypersensitivity to drug or dressings in the trial
- •Patients who are taking or have taken any investigational drugs in 3 months prior to screening.
- •Patients who are taking regular, continuous, oral corticosteroid therapy.
- •Patients undergoing investigations or changes in management for an existing medical condition.
- •Patients who are pregnant or lactating.
- •Patients with diseases or conditions that could interfere with the assessment of safety or efficacy of the IMP.
- •Patients who are not likely to complete the trial.
研究者
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A double blind, placebo controlled, randomised trial to investigate the efficacy of Juvista in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following scar revision surgery. - Juvista in the prevention or reduction of the resultant scar following scar revision surgery.Patients undergoing scar revision surgery are left with scarring, which can vary from fine flat asymptomatic scars to hypertrophic scars. Studies show that these visible marks can cause emotional distress resulting in self-consciousness, loss of self-esteem, stigmatism and diminished quality of life. Scar revision relies on surgical technique to improve scars from complications following surgery, burns, trauma and injury.MedDRA version: 6.1Level: PTClassification code 10039583EUCTR2005-003889-42-GBRenovo
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