A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel (5 mg/g Brimonidine Tartrate) in Patients With Chronic Persistent Vascular Facial Erythema.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 5
- 主要终点
- Efficacy endpoints: Percentage of research participants with at least 1 degree of improvement from baseline in PSE on each moment of post-baseline evaluation
研究概览
简要总结
This study evaluates the efficacy of Mirvaso® in the treatment of chronic persistent vascular facial erythema, after 4 weeks of treatment, by the Clinician erythema assessment.
详细描述
This is a multicenter, open-label trial in research participants with chronic persistent vascular facial erythema. All eligible research participants will receive Mirvaso® gel once daily for 4 weeks, and then will be followed-up for another 2 weeks.
The study will include 4 clinical visits: before Day 1, on Day 1, Day 29 and Week 6.
Within 5 days before Day 1, the research participant will have a screening visit for confirmation of eligibility.
On Day 1 and on Day 29, the research participant will have Mirvaso® gel applied, at the research site, and the evaluation will be conducted before application and 3 hours after application; During Days 2-28, research participants will have Mirvaso® gel applied once daily, at home; On Week 6, the research participants will go back to the research site for evaluation. No Mirvaso® gel will be applied after the visit on Day 29; Unscheduled visits may be performed during the trial for any safety reason.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female research participants aged 18 or higher.
- •Patients with chronic persistent facial erythema (at least 1 month before baseline [Day 1 hour 0]) of rosacea (with no restrictions to subtypes of rosacea), or originated from other dermatological condition, including, but not limited to seborrhoeic dermatitis, ulerythema ophryogenes, keratosis pillaris, microneedling, fractional radiofrequency, post-peeling treatments (medium depth and deep) or post-laser (ablative laser). Diagnosis is based on the investigator clinical judgement.
- •Clinician Erythema Assessment scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1 prior to study treatment administration.
- •Patient Self-Evaluation scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1 prior to study treatment administration.
- •Female patients with childbearing potential and negative pregnancy test at baseline. These patients should use a highly efficient contraceptive method during the study: combined oral contraceptives (estrogen and progesterone) or implanted contraceptives, or injectable contraceptives (with a stable dose for at least 1 month before study enrolment), bilateral tube ligation, hormonal intrauterine device (inserted at least 1 month before study entry), strict abstinence (at least 1 month prior to study entry and agreement in continuing throughout the study), or vasectomized partner (at least 3 months prior to study entry).
- •Female patients without childbearing potential (e.g., before menstruating, post-menopausal [absence of menstrual bleeding for 1 year prior to study entry], hysterectomy, or bilateral oophorectomy, less than one year after menopause).
- •Patients willing and able to fulfill the protocol requirements and duration.
- •Patients who understand and sign the Informed Consent Form at study inclusion, before any study procedure is carried out.
排除标准
- •Any research participant that meets one or more of the following criteria is not eligible for the trial:
- •Female patients who are pregnant, breastfeeding or planning for pregnancy.
- •Current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics or alpha agonists.
- •Patients who started or changed their doses of tricyclic antidepressants, cardiac glycosides, beta-blockers or other anti-hypertensive agents, in the 3 months prior to study entry.
- •Current diagnosis of Raynaud syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, coronary or cerebral insufficiency, hepatic or renal failure, sclerodermia, Sjögren syndrome, or depression.
- •Any chronic or severe uncontrolled disease or medical chronic which may interfere with the interpretation of the study results, or may present a significant healthcare risk to the patient, if he/she participates in the study in accordance with the investigator judgment. (e.g. endocrine tumors, chromocytomas, systemic diseases that cause vascular erythema).
- •Known or suspected allergies or hypersensitivities to any of the components of the study treatments, including the active substance of brimonidine tartrate (see summary of product characteristics).
- •Patients who received, applied or ingested the following treatments in accordance with the time period specified before Day 1:
- •Topic facial treatments or procedures:
- •Any dermatological/surgical facial procedure - 4 weeks. Immunomodulators (e.g. Methotrexate, Cyclosporin) - 4 weeks. Mirvaso® - 4 weeks.
- •Systemic treatments:
- •Isotretinoin - 6 months. Immunomodulators - 90 days. Phototherapy - 4 weeks.
- •Exposure to excessive ultraviolet radiation within a week before Day 1 visit.
- •Presence of beard or excessive facial hair at Day 1, which interferes with the study treatment or study assessments and refusal to remove it during the study period.
- •Patients who do not wish to abstain from the use of forbidden medication or excessive exposure to ultraviolet radiation during the study period.
- •Vulnerable research participants (as deprived of freedom), in accordance with Section 1.61 of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH for Good Clinical Practices.
- •Current participation in any other clinical study with a drug or device OR participation within 30 days prior to Day 1 OR in an exclusion period of a previous clinical study (when possible).
研究组 & 干预措施
Mirvaso® gel
Mirvaso® gel (5 mg/g brimonidine tartrate)
干预措施: brimonidine tartrate (Drug)
结局指标
主要结局
Efficacy endpoints: Percentage of research participants with at least 1 degree of improvement from baseline in PSE on each moment of post-baseline evaluation
时间窗: 1 year
• Facial Erythema based on the Patient self-Evaluation (PSE) evaluated by the research participant on Day 1 (Hour 0 and Hour 3), Day 29 (Hour 0 and Hour 3). All eligible research participants will receive Mirvaso® gel once daily for 4 weeks. The study will include 4 clinical visits: before Day 1, on Day 1, Day 29 and Week 6. * Within 5 days before Day 1, the research participant will have a screening visit for confirmation of eligibility. * On Day 1 and on Day 29, the research participant will have Mirvaso® gel applied, at the research site, and the evaluation will be conducted before application and 3 hours after application; * During Days 2-28, research participants will have Mirvaso® gel applied once daily, at home; No Mirvaso® gel will be applied after the visit on Day 29; • Unscheduled visits may be performed during the trial for any safety reason.
Percentage of research participants with at least 1 degree of improvement from baseline in CEA on each moment of post-baseline evaluation.
时间窗: 1 year
• Facial Erythema based on the Clinician erythema assessment (CEA) evaluated by the investigator on Day 1 (Hour 0 and Hour 3), Day 29 (Hour 0 and Hour 3) . Clinician Erythema Assessment scores: 2 (mild), 3 (moderate), or 4 (severe) . All eligible research participants will receive Mirvaso® gel once daily for 4 weeks. The study will include 4 clinical visits: before Day 1, on Day 1, Day 29 and Week 6. * Within 5 days before Day 1, the research participant will have a screening visit for confirmation of eligibility. * On Day 1 and on Day 29, the research participant will have Mirvaso® gel applied, at the research site, and the evaluation will be conducted before application and 3 hours after application; * During Days 2-28, research participants will have Mirvaso® gel applied once daily, at home; No Mirvaso® gel will be applied after the visit on Day 29; * Unscheduled visits may be performed during the trial for any safety reason.
次要结局
- Evaluate the efficacy of Mirvaso by the Patient Self Evaluation - PSE(1 year)
- Evaluate the efficacy of Mirvaso by the clinician erythema assessment - CEA(1 year)
- Incidence of AEs. Evaluate the safety of Mirvaso(1 year)
- Study Participant Satisfaction Questionnaire(1 year)
- To evaluate the impact in the quality of life after 4 weeks of treatment with Mirvaso(1 year)
- Variation in the overall score in FRQ from baseline visit to each moment of post-baseline evaluation(1 year)