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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.

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: 000-0551 Lotion Drug: Vehicle Lotion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
Study Start Date : June 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Active Arm
Topical lotion, applied twice daily
Drug: 000-0551 Lotion
Placebo Comparator: Vehicle Arm
Topical lotion, applied twice daily
Drug: Vehicle Lotion



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882647


Locations
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United States, Alabama
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
United States, Florida
MOORE Clinical Research, Inc.
Brandon, Florida, United States
Florida Academic Dermatology Center
Miami, Florida, United States
Park Avenue Dermatology, PA
Orange Park, Florida, United States
United States, Indiana
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
United States, New Jersey
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
Academic Dermatology Associates
Albuquerque, New Mexico, United States
United States, Texas
Arlington Research Center, Inc.
Arlington, Texas, United States
DermResearch, Inc.
Austin, Texas, United States
Sponsors and Collaborators
Therapeutics, Inc.
Investigators
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Study Director: Syd Dromgoole, Ph.D. Therapeutics, Inc.
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Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01882647    
Other Study ID Numbers: 000-0551-305
First Posted: June 20, 2013    Key Record Dates
Results First Posted: February 13, 2017
Last Update Posted: February 13, 2017
Last Verified: December 2016
Keywords provided by Therapeutics, Inc.:
psoriasis
lotion
investigator's global assessment
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases