NCT01831180|Completed
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Sponsor study identifier
observational
50
1 country
1
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2013
Actual (reported)April 15, 2013
Actual (reported)September 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 2014
Actual (reported)April 2014
Actual (reported)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.
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.
48 hours after baseline
Hair Chemical Structural information
Baseline
Hair Chemical Structure
48 hours after baseline
Scalp/Hair Care Practices
Baseline
Scalp/Hair Care Practices
48 hours after baseline
Selected from the Wake Forest University Health Sciences Dermatology clinics and responders to Institutional Review Board (IRB) approved advertising
Wake Forest School of Medicine - Dermatology Clinic
Winston-Salem, North Carolina, 27157, United States
Amy McMichael, MD
Wake Forest University Health Sciences
50 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2013
First Posted
April 15, 2013
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562
Contact the study team to confirm eligibility.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
July 6, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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