- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01381445
A Study Assessing GW870086's Potential to Cause Skin Thinning
A Randomised, Double-blind (for GW870086), Placebo-controlled Study of Topical GW870086 Formulation to Explore the Potential for Skin Thinning in Healthy Adult Volunteers
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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Berlin, Tyskland, 10117
- GSK Investigational Site
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: GW870086 0.2% & GW870086 2%
GW870086 0.2%, 2% & placebo each applied to an identified area for 42 days.
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White to slightly coloured opaque cream
White to slightly coloured opaque cream
White to slightly coloured opaque cream
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Experimentell: 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
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White to slightly coloured opaque cream
White to slightly coloured opaque cream
White cream
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change from baseline in skin thickness using ultrasound between GW870086 (0.2% and 2%) versus placebo
Tidsram: Days; 1, 14, 21, 28, 42, 43
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Days; 1, 14, 21, 28, 42, 43
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia
Tidsram: Days; 7, 14, 21, 28, 35, 42, 43
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Days; 7, 14, 21, 28, 35, 42, 43
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The assessment of safety parameters; adverse events, clinical laboratory tests, ECG, and vital signs
Tidsram: 6 weeks
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6 weeks
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Plasma concentrations of GW870086
Tidsram: Days 14 & 42
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Days 14 & 42
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Cmax of GW870086
Tidsram: Days 14 & 42
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Days 14 & 42
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Tmax of GW870086
Tidsram: Days 14 & 42
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Days 14 & 42
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AUC of GW870086
Tidsram: Days 14 & 42
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Days 14 & 42
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Immunsystemets sjukdomar
- Överkänslighet, Omedelbar
- Genetiska sjukdomar, medfödda
- Hudsjukdomar, genetiska
- Överkänslighet
- Hudsjukdomar, eksem
- Dermatit
- Dermatit, atopisk
- Läkemedels fysiologiska effekter
- Antiinflammatoriska medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Clobetasol
Andra studie-ID-nummer
- 113435
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Studiedata/dokument
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Informerat samtycke
Informationsidentifierare: 113435Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analysplan
Informationsidentifierare: 113435Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoterad fallrapportformulär
Informationsidentifierare: 113435Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: 113435Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 113435Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informationsidentifierare: 113435Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: 113435Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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