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Completed

NCT Number: NCT01882647

A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)

This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.

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Key information

Conditions

Plaque Psoriasis 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 3

Primary location

Total Skin and Beauty Dermatology Center, PC, Birmingham, Alabama, 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 involving a minimum of 2% and no more than 12% affected body surface area.
  • Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.
  • If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study

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 (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start.
  • Subject has used any systemic methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to study start.
  • Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five 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 or is intending to have such exposure during the study.
  • Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids, vitamin D analogs) 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 angiotensin converting enzyme (ACE) 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

000-0551 Lotion

Drug

Vehicle Lotion

Drug

Primary outcomes

  1. The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)

    Time frame: Day 15

    The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).

Secondary outcomes

  1. The Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)

    Time frame: Day 15

    A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).

Other outcomes

  1. Percentage of Subjects With IGA "Treatment Success" at Day 8

    Time frame: Day 8

    Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.

  2. Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8

    Time frame: Day 8

    Interim analysis of clinical signs of psoriasis. "Treatment success" for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure.

  3. Change From Baseline in Pruritus Score at Day 15

    Time frame: Baseline and Day 15

    Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).

  4. Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15

    Time frame: Day 15

    The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.

Sponsors and collaborators

Lead sponsor

Therapeutics, Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2013
Registry last updated
Feb 13, 2017

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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