Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair
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ClinicalTrials.gov Identifier: NCT00690664
: June 5, 2008
Last Update Posted
: November 6, 2017
Wake Forest University
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( 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.
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Ages Eligible for Study:
21 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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)