Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034

NCT00358384 | Completed Phase 1

• 1 other identifier: RES104031
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Keywords

tolerability; safety; angiogenesis; vascular endothelial growth factor; pharmacodynamics; pharmacokinetics; microplaque; VEGF; GW786034

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 8 weeks

Secondary Outcomes (1)

• Laser doppler imaging,epidermal thickness by histology skin biopsies Primary pharmacokinetic endpoints AUC(0-t) and Cmax of GW786034 in plasma following repeat dosing

  Up to 8 weeks

Study Arms (6)

Subjects receiving treatment A

EXPERIMENTAL

Eligible subjects will receive 0.1 percent pazopanib ointment.

Drug: Pazopanib

Subjects receiving treatment B

EXPERIMENTAL

Eligible subjects will receive 0.5 percent pazopanib ointment.

Drug: Pazopanib

Subjects receiving treatment C

EXPERIMENTAL

Eligible subjects will receive 1 percent pazopanib ointment.

Drug: Pazopanib

Subjects receiving treatment D

PLACEBO COMPARATOR

Eligible subjects will receive pazopanib vehicle as negative control.

Drug: Pazopanib vehicle

Subjects receiving treatment E

PLACEBO COMPARATOR

Eligible subjects will receive 0.1 percent betamethasone valerate ointment as steroid positive control.

Drug: Betamethasone valerate

Subjects receiving treatment F

PLACEBO COMPARATOR

Eligible subjects will receive 0.005 percent calcipotriol ointment as vitamin D agonist positive control.

Drug: Calcipotriol

Interventions

Pazopanib DRUG

Pazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.

Subjects receiving treatment A; Subjects receiving treatment B; Subjects receiving treatment C

Pazopanib vehicle DRUG

Pazopanib vehicle will be given to subjects.

Subjects receiving treatment D

Betamethasone valerate DRUG

Betamethasone valerate ointment with 0.1 percent concentration will be given to subjects.

Subjects receiving treatment E

Calcipotriol DRUG

Calcipotriol ointment with 0.005 percent concentration will be given to subjects.

Subjects receiving treatment F

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Paris, 75015, France

Location

Related Links

• Results for study RES104031 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Psoriasis

Interventions

pazopanib; Betamethasone Valerate; calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2006
• First Posted: July 31, 2006
• Study Start: September 26, 2005
• Primary Completion: February 24, 2006
• Study Completion: February 24, 2006
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

FR (1)