Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair
2018年7月3日 更新者:Wake Forest University
The purpose of this research study is to better understand African American hair and scalp, its biologic appearance and how this relates to African Americans' perceptions of their hair and scalp health.
Since most hair studies have looked at Caucasian hair and scalp, we will use a population of Caucasian subjects for comparison in evaluating various hair and scalp parameters.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Health Sciences Dermatology
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Healthy female subjects between the ages of 21-60 will be enrolled in this study.
These subjects will be recruited from Wake Forest University Health Sciences Dermatology clinic and our Institutional Review Board (IRB) approved advertising.
Half of the participants will be African American and the other half will be Caucasian.
描述
Inclusion Criteria:
- Must be willing to sign informed consent
- Female from the ages of 21-60 years
- Must be willing to have a thorough scalp and hair shaft examination
- Must be willing to discuss hair care regimen currently and in the past
- Must have washed hair at least 48 hours prior to initial study visit
- Pregnant and nursing females will not be allowed in the study; a baseline pregnancy test will be done to exclude pregnancy on females of childbearing potential
- Must be >6 months (26 weeks) postpartum
- Must have sufficient contrast between scalp skin color and hair color
- Must have hair at least 2 inches long
- May have mild itching and mild scaling of the scalp
- Must be willing to have hair clipped and shaved to 1mm within an approximately 2.5cm test site
- Must be in good stable general health, with no current infections.
Exclusion Criteria:
- May not have sewn-in or glued hair pieces or extensions at the time of the study
- Must not cut hair during the study
- Must not have hair loss beyond what is considered normal in the opinion of the Investigator at the time of the study
- Must not color hair or have other salon-type procedures (relaxer, permanent, highlighting, etc.) performed within 2 weeks of the initial visit
- Must not have any other underlying scalp disorder that could interfere with the test procedures or findings
- Must not have lost ≥10% of body weight within the past 12 months
- Must not have been on a weight reduction program overseen by a physician or nutritionist within the past 12 months
- Has used hair growth products e.g. minoxidil in the past 18 months
- Has undergone a hair transplant or scalp reduction surgery
- Has participated in a hair growth study within the past 15 months
- Is currently participating in another clinical study at this or any other facility
- Is taking, for a chronic condition, any prescription or over the counter medication(s) that in the opinion of the Investigator are likely to affect the hair properties (e.g. immunosuppressive agents, corticosteroids; or chronic use of anti-inflammatory medication)
- Application of any over-the-counter or prescription drug to the scalp on a routine basis within the past 3 months including but not limited to retinoids (e.g. retinal, tretinoin, retinyl palmitate, retinyl acetate, retinyl propionate), topical corticosteroids, benzyl peroxide, or any topical hormone therapy (e.g. Eterna 27)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
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B
Caucasian women
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A
African American women
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Observe comparators of African American and Caucasian women's hair
大体时间:3 days
|
3 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Amy McMichael, MD、Wake Forest University Health Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年4月24日
初级完成 (实际的)
2014年7月14日
研究完成 (实际的)
2014年7月14日
研究注册日期
首次提交
2008年6月2日
首先提交符合 QC 标准的
2008年6月2日
首次发布 (估计)
2008年6月5日
研究记录更新
最后更新发布 (实际的)
2018年7月6日
上次提交的符合 QC 标准的更新
2018年7月3日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.