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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amy McMichael, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00690664
First received: June 2, 2008
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition
Scalp Health

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Observe comparators of African American and Caucasian women's hair [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Hair, both broken strands and those that release from the scalp with bulb intact.


Estimated Enrollment: 60
Study Start Date: April 2007
Estimated Study Completion Date: June 2015
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
B
Caucasian women
A
African American women

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690664

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Amy McMichael, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Amy McMichael, Professor of Dermatology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00690664     History of Changes
Other Study ID Numbers: 00002509, 31716
Study First Received: June 2, 2008
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Hair characteristics

ClinicalTrials.gov processed this record on November 23, 2014