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

3. juli 2018 opdateret af: Wake Forest University
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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Health Sciences Dermatology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
B
Caucasian women
A
African American women

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Observe comparators of African American and Caucasian women's hair
Tidsramme: 3 days
3 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Amy McMichael, MD, Wake Forest University Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. april 2007

Primær færdiggørelse (Faktiske)

14. juli 2014

Studieafslutning (Faktiske)

14. juli 2014

Datoer for studieregistrering

Først indsendt

2. juni 2008

Først indsendt, der opfyldte QC-kriterier

2. juni 2008

Først opslået (Skøn)

5. juni 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB00002509
  • 31716

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med SCALPESHOLD

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