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A Study Assessing GW870086's Potential to Cause Skin Thinning

18. juli 2017 opdateret af: GlaxoSmithKline

A Randomised, Double-blind (for GW870086), Placebo-controlled Study of Topical GW870086 Formulation to Explore the Potential for Skin Thinning in Healthy Adult Volunteers

This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream.

Studieoversigt

Detaljeret beskrivelse

This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. The primary objective of this study is to assess the thickness of the skin using ultrasound. The secondary objectives are to assess skin thinning using a visual scale for skin atrophy and telangiectasia, safety and tolerability of GW870086 and to assess the pharmacokinetics of GW870086 administered as a cream for 42±2 days.

Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream. They will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream. Subjects will apply all 3 treatments once daily during the 42±2 day treatment period. However subjects who are randomised to receive the unblinded clobetasol propionate will only apply this once daily for a maximum of 21±2 days but will continue to dose with the other 2 treatments. If significant evidence of skin thinning is observed in any of the treatment arms (25% reduction in skin thickness measured using ultrasound) then application of this treatment will be discontinued. Three areas of approximately 5 x 5 cm on the arm will be identified and each treatment will be applied to the same area throughout the 42±2 day treatment period.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

      • Berlin, Tyskland, 10117
        • GSK Investigational Site

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

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • AST (Aspartate aminotransferase), ALT (Alanine aminotransferase), alkaline phosphatase and bilirubin ≤ 1.5xULN (Upper limit of normal)(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Healthy as determined by an experienced physician.
  • Male or female between 18 and 55 years of age inclusive.
  • A female subject is eligible to participate if she is of:

    • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the protocol contraception methods if they wish to continue their HRT during the study.

  • Male subjects with female partners of child-bearing potential must agree to use one of the protocol contraception methods.
  • BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
  • Capable of giving written informed consent.
  • Single QTc, QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

Exclusion Criteria:

  • Any sign of weak or fragile skin, striae, or similar, in the areas which will be evaluated.
  • Tattoos or body art on the upper arms.
  • Foreseeable intensive UV exposure during the study (solar or artificial). Subjects must not be exposed to direct sunlight or skin tanning devices (e.g. sunbed) for the duration of the study.
  • A positive pre-study test for Hepatitis B or Hepatitis C antibody within 3 months of screening.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
  • A positive pre-study drug/alcohol screen.
  • A positive test for HIV (Human Immunodeficiency Virus) antibody.
  • History of regular alcohol consumption within 6 months of the study.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • History of sensitivity to any of the study medications or components thereof.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • Subjects who are kept due to regulatory or juridical order in an institution.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GW870086 0.2% & GW870086 2%
GW870086 0.2%, 2% & placebo each applied to an identified area for 42 days.
White to slightly coloured opaque cream
White to slightly coloured opaque cream
White to slightly coloured opaque cream
Eksperimentel: GW870086 2% & Clobetasol Propionate
GW870086 2% & placebo applied to an identified area for 42 days, while Clobetasol Propionate is applied to an area for 21 days
White to slightly coloured opaque cream
White to slightly coloured opaque cream
White cream

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in skin thickness using ultrasound between GW870086 (0.2% and 2%) versus placebo
Tidsramme: Days; 1, 14, 21, 28, 42, 43
Days; 1, 14, 21, 28, 42, 43

Sekundære resultatmål

Resultatmål
Tidsramme
Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia
Tidsramme: Days; 7, 14, 21, 28, 35, 42, 43
Days; 7, 14, 21, 28, 35, 42, 43
The assessment of safety parameters; adverse events, clinical laboratory tests, ECG, and vital signs
Tidsramme: 6 weeks
6 weeks
Plasma concentrations of GW870086
Tidsramme: Days 14 & 42
Days 14 & 42
Cmax of GW870086
Tidsramme: Days 14 & 42
Days 14 & 42
Tmax of GW870086
Tidsramme: Days 14 & 42
Days 14 & 42
AUC of GW870086
Tidsramme: Days 14 & 42
Days 14 & 42

Samarbejdspartnere og efterforskere

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

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

14. april 2011

Primær færdiggørelse (Faktiske)

7. juli 2011

Studieafslutning (Faktiske)

7. juli 2011

Datoer for studieregistrering

Først indsendt

16. juni 2011

Først indsendt, der opfyldte QC-kriterier

23. juni 2011

Først opslået (Skøn)

27. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Formular til informeret samtykke
    Informations-id: 113435
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistisk analyseplan
    Informations-id: 113435
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annoteret sagsbetænkningsformular
    Informations-id: 113435
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasætspecifikation
    Informations-id: 113435
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individuelt deltagerdatasæt
    Informations-id: 113435
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studieprotokol
    Informations-id: 113435
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk undersøgelsesrapport
    Informations-id: 113435
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

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 Dermatitis, atopisk

Kliniske forsøg med GW870086 0.2%

Abonner