A Comparison of Scalp Blood Flow and Hair Shaft In Premenopausal Women Versus Postmenopausal Women
A Comparison of Scalp Blood Flow and Hair Shaft In Premenopausal Women Versus Postmenopausal Women
The purpose of this study is to compare the differences in various chemical and biologic
 parameters of scalp and and hair parameters between young and old Caucasian females. The hair
 state and scalp blood flow in younger and older age groups with typical hair care practices
 will be qualified by measuring various parameters of the hair shaft and scalp with
 correlation back to hair and scalp satisfaction as measured in the subject. This is a single
 center study with an anticipated 4 month enrollment period. The investigators will compare
 various scalp and hair parameters between young and old Caucasian females by obtaining the
 following biological and chemical/structural information. Hair growth rate, anagen to telogen
 ratio, hair density (determined via phototrichogram and digital imaging), Vascular blood flow
 (Laser Doppler Flowmetry), Histamine stimulation and Hair diameter (clipped hairs). In
 addition, a detailed questionnaire will be administered to each subject regarding
 satisfaction of the subject's hair state, including typical hair care regimens and symptoms
 in scalp and/or hair shafts. This information will be correlated to the biologic and
 chemical/structural information about hair and scalp health. Approximately 50 healthy,
 Caucasian female subjects will be enrolled in this study. Twenty five participants will be
 19-25 years-old and 25 participants 60 years or older. There will be two visits, Baseline and
 approximately 48 hours after baseline.
Inclusion Criteria:

 -  Must be willing to sign informed consent

 -  Female in age groups 19-25 years old and 60 years or older

 -  Must be of Caucasian descent, to avoid any ethnic differences in hair biology or
 pigment among different races

 -  Must be willing to have a thorough scalp and hair shaft examination

 -  Must be willing to discuss current and past hair care regimens

 -  Must have washed hair at least 48 hours, but not less than 12 hours prior to study
 visit

 -  Must be willing to not wash hair between Baseline and second 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 (Fitzpatrick
 skin type I-IV)

 -  Must have hair at least 2 inches long

 -  May have mild itching and mild scaling of the scalp, but not dandruff

 -  Must be willing to have hair clipped and shaved to 1 mm within an approximately 1cm2
 test site

 -  Must be a non-smoker for the past 6 months

 -  Must be in good stable general health, with no current infections

 -  Must be able to return to the study site 48 hours after the Baseline visit for the
 second visit.

 Exclusion Criteria:

 -  Must not have hypertension, diabetes, or any neurological disease since all these can
 affect scalp blood flow

 -  Must not take any antihistamines for two weeks prior to the baseline visit and
 throughout the study.

 -  Must not have any known allergy or past history of anaphylaxis to histamine

 -  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, retinylpalmitate, retinyl acetate, retinyl propionate), topical
 corticosteroids, benzyl peroxide, or any topical hormone therapy (e.g. Eterna 27)