Scalp HealthNCT00690664
Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair
An observational study of Scalp Health, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scalp Health
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2007to 14 Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27157
About this study
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
- Keywords
- Hair characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| B | Caucasian women | |
| A | African American women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe comparators of African American and Caucasian women's hair
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study start24 Apr 2007
- Primary completion14 Jul 2014
- Study completion14 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy McMichael, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690664
- Sponsor's protocol ID
- IRB00002509
- Other IDs
- 31716
- Status last verified
- Jul 2018
- First submitted
- 2 Jun 2008
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair
- ClinicalTrials.gov ID
- NCT00690664
- Acronym / sponsor ID
- IRB00002509
- Conditions
- Scalp Health
- Keywords
- Hair characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- 24 Apr 2007 (actual)
- Primary completion
- 14 Jul 2014 (actual)
- Study completion
- 14 Jul 2014 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | – | –Caucasian women |
| A | – | –African American women |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observe comparators of African American and Caucasian women's hair
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy McMichael, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scalp Health, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe comparators of African American and Caucasian women's hair (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.