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Completed

NCT Number: NCT01700985

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

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.

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Key information

Conditions

Psoriasis Plaque Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Therapeutics Clinical Research, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

122-0551

Drug

Applied twice daily for two weeks

Vehicle

Drug

Applied twice daily for two weeks

Primary outcomes

  1. 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

  1. ODS "Treatment Success" at Day 8 and Day 15

    Time frame: baseline, Day 8, and Day 15

    The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "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.

  2. ODS "Improved" at Day 8 and Day 15

    Time frame: baseline, Day 8, and Day 15

    The percentage 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. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.

  3. "Treatment Success" for Clinical Signs and Symptoms of Psoriasis

    Time frame: baseline, Day 8 and Day 15

    The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.

  4. "Improved" for Clinical Signs and Symptoms of Psoriasis

    Time frame: baseline, Day 8 and Day 15

    The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.

  5. Change in % Body Surface Area (BSA) With Psoriasis

    Time frame: baseline, Day 8 and Day 15

    Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.

Sponsors and collaborators

Lead sponsor

Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Oct 4, 2012
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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