NCT03392558已完成不适用
The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea
Burt's Bees Inc.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Investigator Global Assessment of Rosacea Scale Score
研究概览
简要总结
This study evaluates a nature-based sensitive skin regimen (NBSSR), as a suitable adjunct topical application to prescription medication when administered daily over the course of four weeks, in moderate to severe rosacea in comparison to the control regimen (CR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must be female 25-60 years of age with moderate facial rosacea at screening and 6 or 7 papules and/or pustules; as well as, no other known medical conditions that, in the investigator's opinion, may interfere with study participation.
- •Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant(R), Depo-Provera(R) double barrier methods (e.g., condom and spermacide) and abstinence.
- •Subjects must provide written informed consent.
- •Willingness to comply with the study design and procedures.
- •Subjects who agree to sign a photography release form.
排除标准
- •Any dermatological disorder, except rosacea requiring the use of prescription medication, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics,
- •Subjects who are using any anti-aging skin care products within 4 weeks of study enrollment.
- •Subjects who are not willing to use only the assigned study products and nothing else, except for self-selected colored cosmetics that must remain unchanged during the study, to their face.
- •Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- •Subjects, who are pregnant, breast feeding, or planning a pregnancy.
- •Subjects with clinically significant unstable medical disorders.
- •Subjects who are unwilling or unable to comply with the requirements of the protocol.
- •Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- •Subjects who have participated in any clinical study in the past 30 days or are currently participating in any other clinical study.
- •Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.
- •Subjects who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- •Subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day.
- •Subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the initial paperwork.
- •Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation.
研究组 & 干预措施
Nature-Based Sensitive Skin Regimen
Experimental
Burt's Bees Skin Care Regimen (Nature Based Sensitive Skin Regimen, NBSSR):
- Burt's Bees Sensitive Facial Cleanser (to be used day and night)
- Burt's Bees Sensitive Daily Moisturizing Cream (to be used in the day)
- Burt's Bees Sensitive Night Cream (to be used at night)
干预措施: Burt's Bees Skin Care Regimen (Other)
Control Regimen
Active Comparator
Control Skin Care Regimen (Control Regimen, CR):
- Cetaphil Gentle Skin Cleanser (to be used day and night)
- Cetaphil Moisturizing Lotion (to be used day and night)
干预措施: Control Regimen (Other)
结局指标
主要结局
Investigator Global Assessment of Rosacea Scale Score
时间窗: 4 weeks
The primary efficacy endpoint is no increase in the cumulative Investigator Global Assessment of Rosacea Scale score, measured at Week 4 from baseline
次要结局
- Overall Skin Quality(4 weeks)
研究者
研究点 (1)
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