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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01700985
First received: September 27, 2012
Last updated: November 25, 2013
Last verified: November 2013

September 27, 2012
November 25, 2013
May 2012
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01700985 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Psoriasis
  • Plaque Psoriasis
  • Drug: 122-0551
    Applied twice daily for two weeks
  • Drug: Vehicle
    Applied twice daily for two weeks
  • Experimental: 122-0551
    Intervention: Drug: 122-0551
  • Placebo Comparator: Vehicle
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01700985
122-0551-203
No
Therapeutics, Inc.
Therapeutics, Inc.
Not Provided
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.
Therapeutics, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP