Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
12. august 2020 oppdatert av: Allerderm
Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E.
Test allergens in pediatric subjects aged 6-17 years old.
In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study.
The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.
Studietype
Intervensjonell
Registrering (Faktiske)
116
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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California
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San Diego, California, Forente stater, 92123
- Rady Children's Hospital
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Anschutz Health and Wellness Center, University of Colorado
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Dermatology Specialists
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Symptoms and history potentially consistent with allergic contact dermatitis
- Children and adolescents 6-17 years of age, in general good health
- Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion
- Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations
Exclusion Criteria:
- Topical corticosteroid treatment during the last 7 days on or near the test area.
- Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days.
- Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study
- Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks
- Acute dermatitis outbreak or dermatitis on or near the test area on the back
- Subjects unable to comply with activity restrictions (e.g. protecting test panels from excess moisture due to showering or vigorous activity)
- Subjects unable or unwilling to comply with multiple return visits
- Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Positive Response Rates: 7 new and 4 reformulated allergens
Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2.
Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated
|
Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours.
Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
Tidsramme: Investigator Determination of Positive Reaction: 21 days post application
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Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction
|
Investigator Determination of Positive Reaction: 21 days post application
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Late or Persistent Positive Patch Test Reactions
Tidsramme: Day 7-21
|
Late reactions are positive reactions that initially occur at 7-21 days after application of the panels. Persistent reactions are positive reactions that persist from one visit to the next. Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent. |
Day 7-21
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Cory Dunnick, MD, Anschutz Health and Wellness Center, University of Colorado, Aurora, CO
- Hovedetterforsker: Lawrence Eichenfield, MD, Rady Children's Hospital, San Diego
- Hovedetterforsker: Patricia Norris, MD, Oregon Health and Science University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. desember 2012
Primær fullføring (Faktiske)
8. september 2015
Studiet fullført (Faktiske)
8. september 2015
Datoer for studieregistrering
Først innsendt
20. februar 2013
Først innsendt som oppfylte QC-kriteriene
21. februar 2013
Først lagt ut (Anslag)
22. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. august 2020
Sist bekreftet
1. april 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SP 12 7NEW 401
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. .