Topical Brimonidine Reduces IPL-induced Erythema Without Affecting Efficacy: a Randomized Controlled Trial in Patients With Facial Telangiectasias
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Reduction in erythema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation.
研究概览
简要总结
The aim of the study is to investigate whether brimonidine cream can reduce IPL-induced inflammation in terms of redness, swelling and pain in patients with facial vascular lesions (telangiectasias). Furthermore, the effect of brimonidine cream on IPL-efficacy is evaluated one month after final IPL-treatment.
The hypothesis is that brimonidine, which has been proved effective in reduction of symptomatic erythema in patients with rosacea, also may have the ability to reduce IPL-induced erythema. Since the potential reduction in erythema is caused by vasoconstriction, brimonidine may further reduce IPL-induced oedema and pain.
详细描述
Study design The study is designed as a dual-centre, randomized, intra-individual, split-face clinical controlled trial with blinded outcome assessment. A total of 20 patients with moderate to severe facial telangiectasias, without other clinical active dermatological disease in the skin, will be included. Severity and distribution (cheek, nose and chin) of telangiectasias must be symmetrical between facial sides in the individual patient at inclusion. All patients will receive IPL-treatments to both sides of the face. Before the first IPL-treatment, the left and right side of the face will be randomized to either brimonidine (Mirvaso) or only IPL-treatment and air-cooling (control), respectively. The study is conducted in an international collaboration between Bispebjerg Hospital, Department of Dermatology in Denmark and "Skinperium" private practice in Belgium.
Interventions Patients are asked to attend 3 treatment days and 2 follow-up visits. Treatment days are planed with 3 weeks intervals (± 5 days) and follow-up visits are planned at trial day 2 (one day after treatment day 1) and at 1 month (± 5 days) after the final treatment day. The consultations are estimated to last between half an hour and two hours. Patients are further asked to fill out patient diaries in the first 6 days after follow-up visit at trial day 2.
At each treatment day, patients receive 1) IPL of their whole face, 2) brimonidine is thereafter applied to the facial side randomized to treatment followed by 3) air-cooling, which is applied to the whole face of the patient in accordance with clinical guidelines.
Efficacy endpoints & evaluation methods
Primary efficacy endpoint:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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:
- •Injectable, implantable or orally taken hormones;
- •Intrauterine device;
- •Trans-abdominal surgical sterilization;
- •Sterilization implant device;
- •Surgical sterilization of male partner;
- •Complete abstinence from sexual intercourse for two weeks before exposure to study medication and throughout the clinical study
- •Verbal and written consent to participate in the study
- •Documentation of medicine status
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
研究组 & 干预措施
Brimonidine (Mirvaso cream)
This is a split-face study, and patients are thereby their own control. Patients receive IPL-treatment and air-cooling to the whole face (control) and 0.5 g of brimonidine (Mirvaso cream) to the randomized side of the face.
干预措施: Brimonidine (Drug)
IPL+air-cooling
This is a split-face study, and patients are thereby their own control. Patients receive IPL-treatment and air-cooling to the whole face and IPL+air-cooling (control) are thereby compared to IPL+air-cooling+brimonidine (Mirvaso cream).
干预措施: IPL+air-cooling (Other)
结局指标
主要结局
Reduction in erythema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation.
时间窗: Throughout the study, a period of 10 weeks
Erythema is evaluated on the international validated, "Clinician's Erythema Assessment" (CEA) 5-point scale: 0, Clear Clear skin with no signs of erythema 1. Almost clear Almost clear; slight redness 2. Mild Mild erythema; definite redness 3. Moderate Moderate erythema; marked redness 4. Severe Severe erythema; fiery redness
Reduction in oedema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation.
时间窗: Throughout the study, a period of 10 weeks
Oedema is evaluated on a 4-point scale: 0 = no oedema, 1 = little oedema, 2 = moderate oedema and 3 = severe oedema.
次要结局
- The effect of brimonidine on IPL-efficacy quantified by blinded photo-evaluation obtained with a Visia camera, in which baseline-photos are compared to photos from the final follow-up visit.(At the end of the study (after 10 weeks))
- Patient discomfort and pain(Throughout the study, a period of 10 weeks)
- Patient overall satisfaction(Throughout the study, a period of 10 weeks)
研究者
Merete Haedersdal
Professor, MD, DMSc, PhD
Bispebjerg Hospital