A Study Assessing GW870086X's Potential to Cause Skin Thinning

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381445
First received: June 16, 2011
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

This study is a randomised, double-blind, placebo-controlled study of topical GW870086X 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 GW870086X 2% cream, they will also receive either of the following treatments: GW870086X 0.2% cream, or clobetasol propionate 0.05% cream.


Condition Intervention Phase
Dermatitis, Atopic
Drug: GW870086X 0.2%
Drug: GW870086X 2%
Drug: Clobetasol Propionate
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomised, Double-blind (for GW870086X), Placebo-controlled Study of Topical GW870086X Formulation to Explore the Potential for Skin Thinning in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in skin thickness using ultrasound between GW870086X (0.2% and 2%) versus placebo [ Time Frame: Days; 1, 14, 21, 28, 42, 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia [ Time Frame: Days; 7, 14, 21, 28, 35, 42, 43 ] [ Designated as safety issue: No ]
  • The assessment of safety parameters; adverse events, clinical laboratory tests, ECG, and vital signs [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma concentrations of GW870086X [ Time Frame: Days 14 & 42 ] [ Designated as safety issue: No ]
  • Cmax of GW870086X [ Time Frame: Days 14 & 42 ] [ Designated as safety issue: No ]
  • Tmax of GW870086X [ Time Frame: Days 14 & 42 ] [ Designated as safety issue: No ]
  • AUC of GW870086X [ Time Frame: Days 14 & 42 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW870086X 0.2% & GW870086X 2%
GW870086X 0.2%, 2% & placebo each applied to an identified area for 42 days.
Drug: GW870086X 0.2%
White to slightly coloured opaque cream
Drug: GW870086X 2%
White to slightly coloured opaque cream
Drug: Placebo
White to slightly coloured opaque cream
Experimental: GW870086X 2% & Clobetasol Propionate
GW870086X 2% & placebo applied to an identified area for 42 days, while Clobetasol Propionate is applied to an area for 21 days
Drug: GW870086X 2%
White to slightly coloured opaque cream
Drug: Clobetasol Propionate
White cream
Drug: Placebo
White to slightly coloured opaque cream

Detailed Description:

This study is a randomised, double-blind, placebo-controlled study of topical GW870086X 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 GW870086X and to assess the pharmacokinetics of GW870086X administered as a cream for 42±2 days.

Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086X 2% cream. They will also receive either of the following treatments: GW870086X 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381445

Locations
Germany
GSK Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01381445     History of Changes
Other Study ID Numbers: 113435
Study First Received: June 16, 2011
Last Updated: July 28, 2011
Health Authority: Germany: Berlin Ethics Committee

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014