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Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00358384
First Posted: July 31, 2006
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This study is an exploratory study to evaluate the effectiveness, safety and tolerability of three concentrations of GW786034 ointment following treatment to small areas of stable psoriatic plaques. Dosing will proceed using a microplaque approach, where small volumes of ointment will be applied under full occlusion to representative psoriatic plaques. The effectiveness of topical GW786034 treatments and controls will be explored using visual intensity assessments in addition to dermal imaging and histological surrogates of disease activity.

Condition Intervention Phase
Psoriasis Drug: Pazopanib Drug: Pazopanib vehicle Drug: Betamethasone valerate Drug: Calcipotriol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Study to Investigate the Irritation Potential on Healthy Intact Skin and Effect on Psoriatic Skin of Topical Applications of GW786034

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Visual assessment and clinical scoring of lesion treatment areas using modified Psoriasis Area Scoring Index (PASI) target lesion assessment scale Clinical lab tests vital signs adverse events clinical monitoring/observation [ Time Frame: Up to 8 weeks ]

Secondary Outcome Measures:
  • Laser doppler imaging,epidermal thickness by histology skin biopsies Primary pharmacokinetic endpoints AUC(0-t) and Cmax of GW786034 in plasma following repeat dosing [ Time Frame: Up to 8 weeks ]

Enrollment: 10
Actual Study Start Date: September 26, 2005
Study Completion Date: February 24, 2006
Primary Completion Date: February 24, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects receiving treatment A
Eligible subjects will receive 0.1 percent pazopanib ointment.
Drug: Pazopanib
Pazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.
Experimental: Subjects receiving treatment B
Eligible subjects will receive 0.5 percent pazopanib ointment.
Drug: Pazopanib
Pazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.
Experimental: Subjects receiving treatment C
Eligible subjects will receive 1 percent pazopanib ointment.
Drug: Pazopanib
Pazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.
Placebo Comparator: Subjects receiving treatment D
Eligible subjects will receive pazopanib vehicle as negative control.
Drug: Pazopanib vehicle
Pazopanib vehicle will be given to subjects.
Placebo Comparator: Subjects receiving treatment E
Eligible subjects will receive 0.1 percent betamethasone valerate ointment as steroid positive control.
Drug: Betamethasone valerate
Betamethasone valerate ointment with 0.1 percent concentration will be given to subjects.
Placebo Comparator: Subjects receiving treatment F
Eligible subjects will receive 0.005 percent calcipotriol ointment as vitamin D agonist positive control.
Drug: Calcipotriol
Calcipotriol ointment with 0.005 percent concentration will be given to subjects.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Stable (2-3 months) chronic plaque psoriasis covering greater than 5% body surface area (as determined by PASI palm method).
  • Other than having chronic plaque psoriasis, subject is health and ambulatory.
  • Women will be eligible to enter the study if they are of non-child-bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile).
  • Must have at least two clinically similar lesions with the following characteristics as deemed by the dermatologist: Moderate to severe in elevation (thickness), erythema, and scaling (with a total score of at least 6 for each target lesion, when assessed using a 0-4 PASI score). Located on the trunk, buttocks, thighs or upper arms. Are of a sufficient size that will allow the application of three occlusive patches.

Exclusion criteria:

  • Guttate, erythrodermic, or pustular psoriasis.
  • Psoriasis is spontaneously improving.
  • Have had psoriasis that was unresponsive to adequately dosed (> 10 weeks) cyclosporine.
  • Any systemic disorder or active skin disease (other than psoriasis) or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area.
  • History of congestive heart failure (NYHA Class 3 or 4), myocardial infarction, coronary artery bypass graft, percutaneous transluminal balloon angioplasty, cerebrovascular accident, chronic or intermittent oedema.
  • Blood pressure of greater than 150mmHg systolic and /or 95mmHg diastolic following triplicate measurements taken 5 minutes apart.
  • Presence of unstable or severe angina or coronary insufficiency.
  • Uncontrolled bacterial, viral, or fungal infection.
  • Congenital or acquired immunodeficiency.
  • History of malignancy within the last five years, except for surgically cured skin carcinoma or cervical dysplasia (CIN I-II).
  • An unwillingness of male subjects to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant from the time of the first dose of study medication until 5 half-lives of the drug have elapsed following removal of the last dose of study medication.
  • An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of first dose of study medication until five half-lives or 5 days (whichever is longer) following removal of the last dose of study medication.
  • Prolonged exposure to the sun (or tanning beds) during the study.
  • Systemic anti-psoriasis therapy, including but not limited to: acitretin, cyclosporine, isotretinoin, infliximab, entercept, alefacept, oral steroids and psoralen during the 4 weeks prior to the first dose of study medication and throughout the study.
  • Concomitant use of phototherapy or photochemotherapy.
  • Concomitant use of lithium, antimalarials, interferons.
  • Systemic beta-blockers are permitted provided the dose is stable for four weeks before baseline and remains stable throughout the study.
  • Concomitant use of anti-arthritis therapies with known propensity for hepatotoxicity (i.e. diclofenac, gold, D-penicillamine, leflunomide).
  • Use of topical or intralesional treatments for psoriasis (e.g. mid- or high-potency topical corticosteroids) within 2 weeks prior to Day 1 and throughout the study, except for class VI or VII topical steroid treatments (Desonide, or 2.5% hydrocortisone) which will be allowed on the face.
  • Concomitant use of non-drug therapies (i.e. herbal products or alternative therapies) for psoriasis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358384


Locations
France
GSK Investigational Site
Paris, France, 75015
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358384     History of Changes
Other Study ID Numbers: RES104031
First Submitted: July 27, 2006
First Posted: July 31, 2006
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
tolerability
safety
angiogenesis
vascular endothelial growth factor
pharmacodynamics
pharmacokinetics
microplaque
VEGF
GW786034

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents