A Double-Blind, Randomized, Single Center, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment

Therapeutics, Inc.2 sites in 1 country44 target enrollmentMay 2012

ConditionsPsoriasis Plaque Psoriasis

Interventions122-0551 Vehicle

Drugs122-0551 Vehicle

Overview

Phase: Phase 2
Intervention: 122-0551
Conditions: Psoriasis
Sponsor: Therapeutics, Inc.
Enrollment: 44
Locations: 2
Primary Endpoint: Change in Overall Disease Severity (ODS) Score
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

March 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has a clinical diagnosis of stable plaque psoriasis
•Subject has an ODS score for the Treatment Area of 3 or 4 at study start

Exclusion Criteria

•Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
•Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
•Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start
•Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start
•Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start
•Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start
•Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start
•Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start
•Subject is currently using lithium or Plaquenil (hydroxychloroquine)
•Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized

Arms & Interventions

122-0551

Intervention: 122-0551

Vehicle

Intervention: Vehicle

Outcomes

Primary Outcomes

Change in Overall Disease Severity (ODS) Score

Time Frame: baseline and Day 15 (End of Study - EOS)

The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.

Secondary Outcomes

ODS "Improved" at Day 8 and Day 15(baseline, Day 8, and Day 15)
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis(baseline, Day 8 and Day 15)
ODS "Treatment Success" at Day 8 and Day 15(baseline, Day 8, and Day 15)
"Improved" for Clinical Signs and Symptoms of Psoriasis(baseline, Day 8 and Day 15)
Change in % Body Surface Area (BSA) With Psoriasis(baseline, Day 8 and Day 15)