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A Study Assessing GW870086's Potential to Cause Skin Thinning

18 juli 2017 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Berlin, Duitsland, 10117
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Experimenteel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia
Tijdsspanne: 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
Tijdsspanne: 6 weeks
6 weeks
Plasma concentrations of GW870086
Tijdsspanne: Days 14 & 42
Days 14 & 42
Cmax of GW870086
Tijdsspanne: Days 14 & 42
Days 14 & 42
Tmax of GW870086
Tijdsspanne: Days 14 & 42
Days 14 & 42
AUC of GW870086
Tijdsspanne: Days 14 & 42
Days 14 & 42

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 april 2011

Primaire voltooiing (Werkelijk)

7 juli 2011

Studie voltooiing (Werkelijk)

7 juli 2011

Studieregistratiedata

Eerst ingediend

16 juni 2011

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2011

Eerst geplaatst (Schatting)

27 juni 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 juli 2017

Laatste update ingediend die voldeed aan QC-criteria

18 juli 2017

Laatst geverifieerd

1 juli 2017

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Bestudeer gegevens/documenten

  1. Formulier geïnformeerde toestemming
    Informatie-ID: 113435
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistisch analyseplan
    Informatie-ID: 113435
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Geannoteerd casusrapportformulier
    Informatie-ID: 113435
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Specificatie gegevensset
    Informatie-ID: 113435
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Gegevensset individuele deelnemers
    Informatie-ID: 113435
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Leerprotocool
    Informatie-ID: 113435
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisch onderzoeksrapport
    Informatie-ID: 113435
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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