A Study to Test the Effect of 2 Different Doses of Topical GW870086X on Atopic Dermatitis Also Including a Postive Control and a Placebo

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01299610
First received: February 17, 2011
Last updated: February 16, 2012
Last verified: July 2011
  Purpose

This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. Subjects will be assigned to take 3 out of the 4 possible treatments for 21 ±2 days: GW870086X 0.2% cream, GW870086X 2% cream, FP 0.05% cream (as a positive control) and placebo cream. All subjects will be randomised to receive placebo cream. Three index lesions located on the arms and/or legs (one on each) will be identified per subject and each treatment will be applied to the same lesion.


Condition Intervention Phase
Dermatitis, Atopic
Drug: GW870086 2.0%
Drug: GW870086 0.2%
Drug: FP 0.05%
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study of Topical GW870086X Formulation in Subjects With Moderate or Severe Atopic Dermatitis

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline TIS scores between GW870086X (0.2% and 2%) versus placebo at Day 22 [ Time Frame: Day 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline TIS scores between GW870086X (0.2% and 2%) versus placebo on days 2, 3, 7 and 14 [ Time Frame: Days; 2, 3, 7 & 14 of each treatment period ] [ Designated as safety issue: No ]
  • Clinical evaluation of atopic dermatitis using assessment of clinical signs and symptoms according to the Investigators Global Assessment (IGA) [ Time Frame: Day 22 of each treatment period ] [ Designated as safety issue: No ]
  • Assessment of safety parameters; adverse events, clinical laboratory tests, 12-Lead ECG data & vital signs [ Time Frame: 3-5 Weeks ] [ Designated as safety issue: No ]
  • Plasma concentrations and derived pharmacokinetic parameters (Cmax, tmax, AUC) of GW870086X [ Time Frame: Day 22 of each treatment period ] [ Designated as safety issue: No ]
  • Pharmacodynamic endpoints may include skin thickness or other markers of atopic dermatitis, as data permit [ Time Frame: Day 22 of each treatment period ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW870086 2.0% & 0.2%
GW870086 2.0%, GW870086 0.2% & Placebo each applied to a separate specific lesion for 21±2 days.
Drug: GW870086 2.0%
White to slightly colored opaque cream
Drug: GW870086 0.2%
White to slightly colored opaque cream
Drug: Placebo
White to slightly colored opaque cream
Experimental: GW870086 2.0% & FP 0.05%
GW870086 2.0%, FP 0.05% & Placebo each applied to a separate specific lesion for 21±2 days.
Drug: GW870086 2.0%
White to slightly colored opaque cream
Drug: FP 0.05%
White cream
Drug: Placebo
White to slightly colored opaque cream
Experimental: GW870086 0.2% & FP 0.05%
GW870086 0.2%, FP 0.05% & Placebo each applied to a separate specific lesion for 21±2 days.
Drug: GW870086 0.2%
White to slightly colored opaque cream
Drug: FP 0.05%
White cream
Drug: Placebo
White to slightly colored opaque cream

Detailed Description:

This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. The primary objective of this study is to assess 3 lesions using the Three Item Severity (TIS) score. The secondary objectives are to assess safety and tolerability of GW870086X, assess individual lesions using the Investigators Global Assessment (IGA) and to assess the pharmacokinetics of 21 days dosing of GW870086X administered as a cream. Twenty-five (25) subjects with atopic dermatitis will be randomised to receive placebo and 2 of the following treatments: GW870086X 0.2%, GW870086X 2%, FP 0.05% and placebo. All subjects will receive placebo. Subjects will apply all 3 treatments once daily during the 21 day treatment period. Three index lesions located on the arms and/or legs (one on each) will be identified per subject and each treatment will be applied to the same lesion throughout the 21±2 day treatment period. Each index lesion should represent the most common lesions for each patient i.e. not the most or least severe lesions.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of atopic dermatitis who are otherwise healthy.
  • Male or female between 18 and 65 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).
  • Subjects must have body surface area (BSA) disease involvement of >5% as assessed by the rule of nines method.
  • Patients must be willing to refrain from current active therapy for at least 10 days prior to dosing,
  • Capable of giving written informed consent.
  • Single QTc, QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
  • AST and ALT < 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

Exclusion Criteria:

  • The subject presents with any systemic disorder, active skin disease or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening.
  • The subject has atopic dermatitis restricted to the face, the feet or the hands only.
  • The subject has a current complication of atopic dermatitis for which treatment with anti-infectives are indicated.
  • History of recent (< 6 months) active or presence of current superficial skin infections of viral aetiology
  • The subject has been diagnosed as having contact dermatitis in area of target lesions, seborrheic dermatitis and/or occupational eczema at predilection sites of atopic dermatitis.
  • The subject has had topical or transdermal treatments on or near the intended site of application within 14 days prior to first application of study medication.
  • The subject has had systemic treatment for atopic dermatitis within 28 days of the first dose of study medication.
  • Foreseeable intensive UV exposure during the study. Subjects must not be exposed to direct sunlight or skin tanning devices for the duration of the study.
  • The subject has used topical treatment with tar or any corticosteroid within 14 days of the first dose of study medication except topical 1% hydrocortisone which may be used twice daily in patients with severe disease who require step-down therapy during the wash-out period until 3 days prior to study start, after which the hydrocortisone must be discontinued.
  • The subject has used topical treatment with buproprion within 14 days of the first dose of study medication.
  • History of cutaneous photodisorder.
  • History of allergy to steroids or components of test medications.
  • History or presence of skin (other than atopic dermatitis), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
  • Subjects with a history of diaphoresis/excessive sweating not restricted to palms or face.
  • A positive test for Hepatitis B or Hepatitis C antibody.
  • 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 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.
  • 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.
  • 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: NCT01299610

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: NCT01299610     History of Changes
Other Study ID Numbers: 113434
Study First Received: February 17, 2011
Last Updated: February 16, 2012
Health Authority: Germany: Berlin Ethics Committee

Keywords provided by GlaxoSmithKline:
Atopic Dermatitis
GW870086X
TIS
IGA

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014