HealthyNCT01831180
A Comparison of Scalp Blood Flow and Hair Shaft In Premenopausal Women Versus Postmenopausal Women
An observational study of Healthy, run by Wake Forest University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Selected from the Wake Forest University Health Sciences Dermatology clinics and responders to Institutional Review Board (IRB) approved advertising
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine - Dermatology Clinic
Winston-Salem, North Carolina, 27157
About this study
Official title: A Comparison of Scalp Blood Flow and Hair Shaft In Premenopausal Women Versus Postmenopausal Women: II-Scalp & Blood Flow 2012
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.
- Conditions
- Healthy
- Keywords
- hair, scalp, blood flow, Caucasian, Histamine stimulation, Wake Forest
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 |
|---|---|---|
| Premenopausal women 19-25 yrs | Not described | |
| Postmenopausal 60 yrs + | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scalp/Hair Biological Structural
Two areas will be tested in total; one site on the scalp (parietal scalp: which is the area between top of the scalp and either ear) and one area on the forearm. Study staff will take a template and mark off the designated scalp area with a marker. This temporary ink mark will be used as a reference point. The hairs in the marked area (approximately the size of a nickel) will be cut and clipped to 1 millimeter in length for analysis. A digital photographic image of the scalp and hair shafts (phototrichogram) will be taken at the clipped hair site of the scalp. The temporary ink mark that was placed during hair cutting/clipping will be used as a reference point to position the image for capture and storage.
Measured: Baseline
Scalp/Hair Biological Structural
A site on the forearm will be marked as control on the second visit for laser blood flow measurements. Forearm and scalp blood flow will be assessed with Laser Doppler Imager (LDI) on the marked sites. Scalp reactive hyperemia (scalp blood flow) will be measured by injecting just under the skin a small amount of histamine (100 µg of histamine dihydrochloride in 1 ml normal saline) using small needle at both the chosen scalp and forearm sites. Then the blood flow measurement with the LDI will be repeated at the above mentioned sites 1 minute after histamine injection. The study staff will take another digital image (phototrichogram) of the clipped scalp area. The temporary ink mark placed during the baseline visit will serve as a reference point.
Measured: 48 hours after baseline
Secondary outcomes (2)
Hair Chemical Structural information
Chemical/Structural information Hair diameter (clipped hairs: Hair fiber diameter will be measured on the recovered hair from the initial clipping site. The analysis will be completed at an external laboratory using the OFDA100 instrument.
The OFDA100 method allows measurement of the hair diameter from all of the individual hairs in the sample - enabling analysis of the diversity of the population of hairs. This method enables looking at the overall diameter of the population in a single sample, comparing the number of modes, the proportion of each mode, and also the individual diameters and variability of each mode.
Measured: Baseline
Hair Chemical Structure
Chemical/Structural information Hair diameter (clipped hairs: Hair fiber diameter will be measured on the recovered hair from the initial clipping site. The analysis will be completed at an external laboratory using the OFDA100 instrument.
The OFDA100 method allows measurement of the hair diameter from all of the individual hairs in the sample - enabling analysis of the diversity of the population of hairs. This method enables looking at the overall diameter of the population in a single sample, comparing the number of modes, the proportion of each mode, and also the individual diameters and variability of each mode.
Measured: 48 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Amy McMichael, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831180
- Sponsor's protocol ID
- IRB00022675
- Status last verified
- Jul 2018
- First submitted
- 2 Apr 2013
- 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
- A Comparison of Scalp Blood Flow and Hair Shaft In Premenopausal Women Versus Postmenopausal Women: II-Scalp & Blood Flow 2012
- ClinicalTrials.gov ID
- NCT01831180
- Acronym / sponsor ID
- IRB00022675
- Conditions
- Healthy
- Keywords
- hair, scalp, blood flow, Caucasian, Histamine stimulation, Wake Forest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Apr 2013 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal women 19-25 yrs | – | – |
| Postmenopausal 60 yrs + | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Selected from the Wake Forest University Health Sciences Dermatology clinics and responders to Institutional Review Board (IRB) approved advertising
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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
Scalp/Hair Biological Structural
Time frame: Baseline
Two areas will be tested in total; one site on the scalp (parietal scalp: which is the area between top of the scalp and either ear) and one area on the forearm. Study staff will take a template and mark off the designated scalp area with a marker. This temporary ink mark will be used as a reference point. The hairs in the marked area (approximately the size of a nickel) will be cut and clipped to 1 millimeter in length for analysis. A digital photographic image of the scalp and hair shafts (phototrichogram) will be taken at the clipped hair site of the scalp. The temporary ink mark that was placed during hair cutting/clipping will be used as a reference point to position the image for capture and storage.
Scalp/Hair Biological Structural
Time frame: 48 hours after baseline
A site on the forearm will be marked as control on the second visit for laser blood flow measurements. Forearm and scalp blood flow will be assessed with Laser Doppler Imager (LDI) on the marked sites. Scalp reactive hyperemia (scalp blood flow) will be measured by injecting just under the skin a small amount of histamine (100 µg of histamine dihydrochloride in 1 ml normal saline) using small needle at both the chosen scalp and forearm sites. Then the blood flow measurement with the LDI will be repeated at the above mentioned sites 1 minute after histamine injection. The study staff will take another digital image (phototrichogram) of the clipped scalp area. The temporary ink mark placed during the baseline visit will serve as a reference point.
2 secondary outcomes
Hair Chemical Structural information
Time frame: Baseline
Hair Chemical Structure
Time frame: 48 hours after baseline
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 Healthy, 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 16 inclusion and 16 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?
Scalp/Hair Biological Structural (time frame: Baseline). The study lists 2 primary outcomes in all. 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.