跳至主要内容
临床试验/EUCTR2015-004789-27-DK
EUCTR2015-004789-27-DK进行中(未招募)1 期

Topical brimonidine to reduce post-inflammatory response after IPL- treatment and effect on IPL-efficacy in patients with facial telangiectasias - Topical brimonidine to reduce post-inflammatory response after IPL- treatment and effect on IPL-effi

Bispebjerg Hospital0 个研究点目标入组 20 人开始时间: 2015年12月8日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
20

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
All

入选标准

  • Patients with moderate to severe facial telangiectasias referred to laser or IPL-treatment. Severity and distribution of telangiectasias must
  • be symmetrical between left and right side of the face in the individual patient
  • Telangiectasias may be observed in connection with rosacea, but rosacea must not demonstrate clinical active inflammation or acne
  • 18-65 years of age
  • Fitzpatrick skin type I-III
  • Fertile women must document non-reactive urine pregnancy test at the day of inclusion
  • During the study, fertile women must be using effective birth control.Effective contraception is defined as follows:
  • o Hormonal contraceptive (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) o Intrauterine device;
  • o Trans-abdominal surgical sterilization;
  • o Sterilization implant device;
  • o Surgical sterilization of male partner (given that the subject is monogamaous);
  • Verbal and written consent to participate in the study
  • Documentation of medicine status
  • 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 20
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Clinical active dermatological disease in the face
  • Wounds, dermatitis, tattoos or scars in treatment area
  • Allergies to ingredients in Mirvaso
  • Current treatment with monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants which interacts with the noradrenergic transmission
  • Current treatment with other systemic adrenergic receptor agonists or antagonists
  • Patients with known liver or renal disease
  • UV-exposure (solarium or sunbathing) or other treatment within the last month that enhances skin pigmentation
  • Use of other topical agents that may interact with treatment
  • Local or systemic treatment with photosensitizing drugs
  • Pregnancy and breastfeeding women
  • Current participation in other clinical trials
  • Patients that are considered incapable of complying with the protocol, i.e. patients suffering from dementia, alcoholism or psychiatric conditions

研究者

相似试验