Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: Pazopanib; Drug: Pazopanib vehicle; Drug: Calcipotriol; Drug: Betamethasone valerate

• Registration Number: NCT00358384
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-26
• Primary Completion: 2006-02-24
• Study Completion: 2006-02-24
• Study First Submitted: 2006-07-27
• Study First Submitted QC: 2006-07-27
• Study First Posted: 2006-07-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects receiving treatment C	Pazopanib	Eligible subjects will receive 1 percent pazopanib ointment.
Subjects receiving treatment D	Pazopanib vehicle	Eligible subjects will receive pazopanib vehicle as negative control.
Subjects receiving treatment F	Calcipotriol	Eligible subjects will receive 0.005 percent calcipotriol ointment as vitamin D agonist positive control.
Subjects receiving treatment A	Pazopanib	Eligible subjects will receive 0.1 percent pazopanib ointment.
Subjects receiving treatment B	Pazopanib	Eligible subjects will receive 0.5 percent pazopanib ointment.
Subjects receiving treatment E	Betamethasone valerate	Eligible subjects will receive 0.1 percent betamethasone valerate ointment as steroid positive control.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇫🇷 Paris, France