Clinical trial NCT01700985: A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Plaque Psoriasis
Keywords: psoriasis
plaque psoriasis
122-0551
steroid
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Change in Overall Disease Severity (ODS) Score
timeFrame: baseline and Day 15 (End of Study - EOS)
Secondary outcomes:
measure: ODS "Treatment Success" at Day 8 and Day 15
timeFrame: baseline, Day 8, and Day 15
measure: ODS "Improved" at Day 8 and Day 15
timeFrame: baseline, Day 8, and Day 15
measure: "Treatment Success" for Clinical Signs and Symptoms of Psoriasis
timeFrame: baseline, Day 8 and Day 15
measure: "Improved" for Clinical Signs and Symptoms of Psoriasis
timeFrame: baseline, Day 8 and Day 15
measure: Change in % Body Surface Area (BSA) With Psoriasis
timeFrame: baseline, Day 8 and Day 15
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
affiliation: Therapeutics, Inc.
name: Syd Dromgoole, PhD
role: STUDY_DIRECTOR
References: