A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Psoriasis Plaque Psoriasis	Drug: 122-0551 Drug: Vehicle	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Therapeutics, Inc.:

Primary Outcome Measures:

Change in Overall Disease Severity (ODS) Score [ Time Frame: baseline and Day 15 (End of Study - EOS) ] [ Designated as safety issue: No ]
The proportion 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 Outcome Measures:

ODS "treatment success" at Day 8 and Day 15 [ Time Frame: baseline, Day 8, and Day 15 ] [ Designated as safety issue: No ]
The proportion of subjects with ODS "treatment success" at Day 8 and Day 15.
ODS "improved" at Day 8 and Day 15 [ Time Frame: baseline, Day 8, and Day 15 ] [ Designated as safety issue: No ]
The proportion of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline.
"Treatment success" for clinical signs and symptoms of psoriasis [ Time Frame: baseline, Day 8 and Day 15 ] [ Designated as safety issue: No ]
The proportion of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15.
"Improved" for clinical signs and symptoms of psoriasis [ Time Frame: baseline, Day 8 and Day 15 ] [ Designated as safety issue: No ]
The proportion of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15.
Change in % body surface area (BSA) with psoriasis [ Time Frame: baseline, Day 8 and Day 15 ] [ Designated as safety issue: No ]
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.

Enrollment:	44
Study Start Date:	May 2012
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 122-0551	Drug: 122-0551 Applied twice daily for two weeks
Placebo Comparator: Vehicle	Drug: Vehicle Applied twice daily for two weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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., propanolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized
Subject is pregnant, lactating, or is planning to become pregnant during the study
Subject is currently enrolled in an investigational drug or device study
Subject has used an investigational drug or investigational device treatment within 30 days prior to study start
Subject has been previously enrolled in this study and treated with a test article

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700985

Locations

United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759

Sponsors and Collaborators

Therapeutics, Inc.

Investigators

Study Director:

Syd Dromgoole, PhD

Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01700985 History of Changes
Other Study ID Numbers:	122-0551-203
Study First Received:	September 27, 2012
Last Updated:	October 2, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Therapeutics, Inc.:

psoriasis
plaque psoriasis
122-0551
steroid

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013