Clinical trial NCT00690664: Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair
Official title: Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scalp Health
Keywords: Hair characteristics
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Observe comparators of African American and Caucasian women's hair
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Amy McMichael, MD
role: PRINCIPAL_INVESTIGATOR
References: