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
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
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