- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00879944
Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index
Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Several environmental factors and comorbid conditions have been found to be associated with psoriasis in adults, including obesity, depression, smoking, and other cardiovascular risk factors such as high blood pressure. The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
This is a multi-center study with a planned total enrollment of about 200 subjects ages 2-17 years old with psoriasis and 100 aged-match controls. Patient and family history will be recorded. All subjects will undergo standard height, weight, blood pressure, and waist circumference (WC). For the obese and overweight subjects we will also obtain their growth charts to attempt to correlate weight gain with psoriasis onset and progression. All data will be compiled and then statistically analyzed.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada
- Nexus Clinical Resarch
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Santiago, Chile
- Pontificia universidad catolica de Chile
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California
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San Diego, California, Forente stater, 92123
- University of California, San Diego
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San Francisco, California, Forente stater, 94143
- University of California, San Francisco
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Stanford, California, Forente stater, 94305
- Stanford University School of Medicine
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01605
- UMass Memorial Dermatology Center
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Missouri
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St. Louis, Missouri, Forente stater, 63117-1206
- Central Dermatology
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals, Case Medical Centers
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Texas
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Dallas, Texas, Forente stater, 75246
- Texas Dermatology Associates
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Houston, Texas, Forente stater, 77030
- Texas Children's Hospital
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Tuen Mun, Hong Kong
- University of Hong Kong
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Verona, Italia
- Universita Verona
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Nijmegen, Nederland
- UMC St. Radboud
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
- Children ages 5 to 17 years old with either moderate or severe plaque type psoriasis
- Children ages 5 to 17 years old with moderate or severe atopic dermatitis
- Children ages 5 to 17 years old seen in dermatology clinic who are healthy and without a systemic disorder.
Beskrivelse
Inclusion Criteria:
- Subjects must be between the ages of 5 and 17 years at the time of enrollment.
- Subjects of either sex.
- Subjects who have had psoriatic plaques for more than 6 months.
- Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol.
- Subjects enrolled as "non-inflammatory" normal controls will carry a common non- systemic skin condition, such as acne, nevi, warts and molluscum as their main diagnosis.
- Subjects enrolled as "inflammatory" normal controls will carry a diagnosis of moderate to severe atopic dermatitis.
Exclusion Criteria:
- Subjects who are unable to give informed consent or assent.
- Subjects who have had psoriasis for less than 6 months.
- Subjects whose condition is deemed unsafe or incapable by the study investigator for study participation.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Psoriasis
Children ages 5-17 years old with moderate or severe plaque type psoriasis.
Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
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Blood pressure will be measured once while patient is seated
Height will be measured in centimeters at the time of enrollment
Weight will be measured in kilograms at enrollment
Body Mass Index (BMI) will be calculated from a subject's height and weight
Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
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Atopic Dermatitis Controls
Children ages 5 to 17 years old with moderate to severe atopic dermatitis.
Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
|
Blood pressure will be measured once while patient is seated
Height will be measured in centimeters at the time of enrollment
Weight will be measured in kilograms at enrollment
Body Mass Index (BMI) will be calculated from a subject's height and weight
Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
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Healthy Controls
Children 5-17 years of age who are healthy and seen in dermatology clinic for a non-systemic skin condition. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm |
Blood pressure will be measured once while patient is seated
Height will be measured in centimeters at the time of enrollment
Weight will be measured in kilograms at enrollment
Body Mass Index (BMI) will be calculated from a subject's height and weight
Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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BMI
Tidsramme: 07/2010
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07/2010
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Blood Pressure
Tidsramme: 07/2010
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07/2010
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Waist circumference
Tidsramme: 07/2010
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07/2010
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AP-2009-13793
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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AmgenFullførtPsoriasis-type psoriasis | Plakk-type psoriasisForente stater
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Innovaderm Research Inc.FullførtPsoriasis i hodebunnen | Pustuløs Palmo-plantar Psoriasis | Ikke-pustulær Palmo-plantar Psoriasis | Psoriasis i albuen | Psoriasis i underbenetCanada
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UCB Biopharma S.P.R.L.FullførtModerat til alvorlig psoriasis | Generalisert pustuløs psoriasis og erytrodermisk psoriasisJapan
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Janssen Pharmaceutical K.K.RekrutteringGeneralisert pustulær psoriasis | Erytrodermisk psoriasisJapan
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Eli Lilly and CompanyFullførtGeneralisert pustulær psoriasis | Erytrodermisk psoriasisJapan
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TakedaRekrutteringGeneralisert pustulær psoriasis | Erytrodermisk psoriasisJapan
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PfizerFullførtPsoriasis Vulgaris | Pustuløs psoriasis | Psoriasis Arthropathica | Erytrodermisk psoriasisJapan
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ExThera Medical Europe BVExThera Medical Corporation; Vivantes Clinic NeuköllnRekrutteringBlodstrømsinfeksjonFrankrike, Tyskland, Nederland, Østerrike, Belgia, Italia, Polen, Spania, Storbritannia
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Ascensia Diabetes CareFullført
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Bispebjerg HospitalUniversity College Absalon; Danske FysioterapeuterAktiv, ikke rekrutterendeJumpers kne | Patellar tendinopatiDanmark
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Mayo ClinicFullført
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Lauren EricksonAmerican College of Sports MedicineFullførtPatellofemoralt syndromForente stater