- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00867607
Safety, Tolerability, and Efficacy of 21 Days Dermal Application of MRX-6 on Mild to Moderate Contact Dermatitis
19. april 2015 oppdatert av: Hadassah Medical Organization
A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of Three Weeks of Daily Dermal Application of MRX-6 (2% HyPE) on the Treatment of Mild to Moderate Contact Dermatitis of the Hand and Forearm
A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of Three Weeks of Daily Dermal Application of MRX-6 or steroid on the Treatment of Mild to Moderate Allergic Contact Dermatitis of the Hand and Forearm.
Total number of patients: up to 80.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
13
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Ein Karem, Jerusalem, Israel
- Department of Dermatology, Hadassah Hospital
-
Jerusalem, Israel
- dermatology department, Hadassah university hospital
-
-
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
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adult men and women between 18 and 65 years old.
- Male or non-pregnant female subjects who agree to comply with applicable contraceptive requirements of the protocol. Details on potential child-bearing status, methods to regularly exclude pregnancy throughout the study and acceptable forms of contraception are provided in Section 3.4.1 of the protocol.
- Satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, clinical or laboratory evaluation [hematology, biochemistry, urinalysis]) as determined by the Principal Investigator, that might interfere with the assessment of the subjects dermatitis or the assessment of the safety or efficacy of the Study Drug.
- The subject must understand and be able, willing and likely to fully comply with study procedures and restrictions.
- Subject can understand and provide written informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures listed in Section 5.1.1 of the protocol.
- Subject has mild to moderate bilateral allergic contact dermatitis on each hand, possibly extending to the forearm, according to Physicians Visual Assessment as described in Section 5.2.1 of the protocol. Mild to moderate disease is considered a PVA score of 10 or greater and there should be no more than a 1-point difference between hands.
- Have a + reaction to the Standard European Series patch testing kit (Chemotechnique Diagnostics Products, Malmo, Sweden) after application for 2 days, as described in Section 5.2.2 of the protocol.
Exclusion Criteria:
- Current or recurrent disease that could affect the action, absorption or disposition of the Study Drug, or clinical or laboratory assessments.
- Have used topical antihistamines in the past 2 weeks, topical corticosteroids or received Psoralen plus ultra violet light therapy (PUVA) in the past 4 weeks, or have taken oral retinoids, corticosteroids in the past 8 weeks (inhaled or intranasal corticosteroids are allowed, if stable dose).
- Use of any prescription or OTC medication (excluding hormonal contraceptive, hormonal replacement therapy, inhaled or intranasal corticosteroids , or oral NSAIDs) that, in the opinion of the Principal Investigator, could affect (improve or worsen) the condition being studied, or could affect the action, absorption or disposition of the Study Drug, or clinical or laboratory assessments.
- Patients must not have used another investigational product or taken part in a clinical trial within the last 30 days prior to enrolment.
- Female patients who are pregnant or lactating, including females with a positive pregnancy test at screening, must be excluded.
- The subject known to have a positive hepatitis virus test (Hepatitis B virus surface antigen or hepatitis C virus antibody) or a positive human immunodeficiency virus (HIV) antibody test.
- A history of hypersensitivity to any of the Study Drugs or their excipients.
- Subject has any other significant dermatological condition that affects >10% of the body surface area or general medical condition that could interfere with the study evaluation
- Subject has any significant medical condition that could compromise immune responsiveness
- Subject has a history of alcoholism or drug abuse
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Steroid
|
b.i.d. 21 days
|
Eksperimentell: MRX-6 (2%)
|
b.i.d treatment for 21 days
|
Eksperimentell: MRX-6 (1%)
|
b.i.d treatment for 21 days
|
Eksperimentell: MRX-6 (0.2%)
|
b.i.d treatment for 21 days
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The safety and tolerability of three dose levels of topical MRX-6 (0.2%, 1.0% and 2% HyPE) when administered twice daily (b.i.d.) for 21 consecutive days
Tidsramme: Day 21
|
Day 21
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Difference in percentage change in each subject's total Physician's Visual Assessment (PVA) score from Baseline to Day 21 between the vehicle and MRX-6 treated hands/forearms.
Tidsramme: Day 21
|
Day 21
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yuval Ramot, MD, Hadassah university hospital, Jerusalem Israel
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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
1. mars 2011
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. mars 2014
Datoer for studieregistrering
Først innsendt
22. mars 2009
Først innsendt som oppfylte QC-kriteriene
22. mars 2009
Først lagt ut (Anslag)
24. mars 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. april 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. april 2015
Sist bekreftet
1. mars 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MRX6-201ver4-HMO-CTIL
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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