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

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ClinicalTrials.gov Identifier: NCT01882647
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 18, 2013
First Posted Date  ICMJE June 20, 2013
Results First Submitted Date  ICMJE March 10, 2016
Results First Posted Date  ICMJE February 13, 2017
Last Update Posted Date February 13, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Proportion 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Proportion 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).
Current Other Pre-specified Outcome Measures
 (submitted: December 20, 2016)
  • 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.
  • 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.
  • 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).
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: June 18, 2013)
  • Proportion 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.
  • Proportion 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" and clinical signs as defined in the secondary outcome measure.
  • 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).
  • Change in % body surface area (BSA) with active psoriasis at Days 8 and 15 [ Time Frame: Baseline, Day 8 and 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.
 
Descriptive Information
Brief Title  ICMJE A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: 000-0551 Lotion
  • Drug: Vehicle Lotion
Study Arms  ICMJE
  • Experimental: Active Arm
    Topical lotion, applied twice daily
    Intervention: Drug: 000-0551 Lotion
  • Placebo Comparator: Vehicle Arm
    Topical lotion, applied twice daily
    Intervention: Drug: Vehicle Lotion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2014)
222
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2013)
200
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01882647
Other Study ID Numbers  ICMJE 000-0551-305
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutics, Inc.
Study Sponsor  ICMJE Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Syd Dromgoole, Ph.D. Therapeutics, Inc.
PRS Account Therapeutics, Inc.
Verification Date December 2016

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