Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair

NCT ID: NCT00690664

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-04-24
• Study Completion Date: 2014-07-14

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.

Conditions

Scalp Health

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

B

Caucasian women

No interventions assigned to this group

A

African American women

No interventions assigned to this group

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy McMichael, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

31716

Identifier Type: -

Identifier Source: secondary_id

IRB00002509

Identifier Type: -

Identifier Source: org_study_id