NCT03841032已完成不适用
4 Week In-Use Study Evaluating the Tolerability of a Skin Care Product on Adults With Rosacea
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of subjects exhibiting increases in any subjective irritation
研究概览
简要总结
The purpose of this study is to evaluate if the test sunscreen skin care product will be well-tolerated and help facial redness when applied to the face after 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 females at least 18 years of age;
- •Women of childbearing potential must agree to use adequate contraception when sexually active. Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception (stable dose for 3 months); (v) partner vasectomy.
- •Subjects with general good health as determined by a medical history form;
- •Subjects with erythematotelangiectatic and/or papulopustular rosacea, at the baseline evaluation, as determined by the Investigator;
- •Subjects with Fitzpatrick Skin Types I through III, as determined by the dermatologist;
- •Subjects willing and capable of understanding and providing written informed consent, willing to sign a confidentiality agreement, Health Insurance Portability and Accountability Act (HIPAA) Authorization Form, and to cooperate and participate by following study requirements.
排除标准
- •Subjects with only phymatous or ocular rosacea;
- •Female subjects of child-bearing potential who test positive in a urine pregnancy test at Baseline (Visit 1), are trying to become pregnant or are nursing;
- •Subjects with known allergies to any type of skin care product and/or sunscreen product and/or any ingredients in the test product;
- •Subjects with any facial skin disorders which may influence results, in the opinion of the Investigator;
- •Subjects with a reported history of acute or chronic dermatological (except for rosacea), uncontrolled hypertension, other medical and/or physical conditions which, in the opinion of the Investigator, interferes with evaluation of the test product or places the subject at risk;
- •Subjects currently using medications or oral supplements which, in the opinion of the Investigator, may influence the outcome of the study or interfere with study observations, including rosacea treatment products;
- •Individuals using or who have used any systemic medication considered to affect rosacea, specifically, but not exclusively, antibiotics or steroids, who do not agree to continue taking the specified medication at the same dose and regimen throughout 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 with excessive facial hair that would, in the opinion of the Investigator, interfere with diagnosis or assessment of rosacea;
- •Subjects who spend excessive time out in the sun;
- •Subjects that have received or used an Investigational New Drug within 30 days prior to the study.
研究组 & 干预措施
Sunscreen Lotion
Experimental
Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks
干预措施: Coppertone, BAY1183345 (Drug)
结局指标
主要结局
Number of subjects exhibiting increases in any subjective irritation
时间窗: Up to 4 weeks
Number of subjects exhibiting increases in erythema
时间窗: Up to 4 weeks
Number of subjects exhibiting increases in papules
时间窗: Up to 4 weeks
Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness
时间窗: Up to 4 weeks
次要结局
- Change in facial redness measured by spectrophotometer(From baseline up to 4 weeks)
- Change in facial redness measured by digital imaging(From baseline up to 4 weeks)
- Percentages for each response to hedonic questionnaire assessing product experience(Up to 4 weeks)
研究者
研究点 (1)
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