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A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)

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ClinicalTrials.gov Identifier: NCT02742441
Recruitment Status : Completed
First Posted : April 19, 2016
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Brief Summary:
This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: 122-0551 Foam Drug: Vehicle Foam Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)
Study Start Date : June 2016
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : June 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 122-0551 Foam

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

Drug: 122-0551 Foam
Topical Foam containing active drug

Placebo Comparator: Vehicle Foam

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Drug: Vehicle Foam
Topical Foam containing no active drug




Primary Outcome Measures :
  1. 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 taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.


Secondary Outcome Measures :
  1. Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) [ Time Frame: Day 15 ]
    Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.


Other Outcome Measures:
  1. Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) [ Time Frame: Day 8 ]
  2. Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) [ Time Frame: Day 8 ]
  3. Change From Baseline in Pruritus Score [ Time Frame: Day 15 ]
    At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed and scored (range 1-5) using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. Possible total scores range from 5 (no pruritus) to 25 (most severe pruritus). At Day 15, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire.

  4. Changes in Percent BSA With Active Psoriasis in the Treatment Area [ Time Frame: Day 15 ]
    The percent (%) Body Surface Area (BSA) with active psoriasis in the Treatment Area will be determined at the Baseline Visit and Week 2 (Day 15) and documented. At Baseline, the percent BSA with active psoriasis in the Treatment Area must be 2% to 12%, inclusive.



Information from the National Library of Medicine

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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:

  1. Subject is male or non-pregnant female and is at least 18 years of age at the time of the Screening Visit.
  2. Subject has provided written informed consent.
  3. Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
  4. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas).
  5. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
  6. Females must be post-menopausal , surgically sterile or use an effective method of birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.

Exclusion Criteria:

  1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
  2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
  3. Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
  4. 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 the Baseline Visit.
  5. 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 the Baseline Visit.
  6. Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five (5) half-lives of the biologic prior to the Baseline Visit. Published or documented half-life of the product provided by the commercial supplier or Sponsor should be used to establish this value.
  7. Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study which in the opinion of the investigator is thought to modify the subject's disease.
  8. Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the Baseline Visit.
  9. Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
  10. Subject is currently using lithium or Plaquenil (hydroxychloroquine).
  11. Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator.
  12. Subject has a history of sensitivity to any of the ingredients in the test articles.
  13. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  14. Subject is currently enrolled in an investigational drug or device study.
  15. Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
  16. Subject has been previously enrolled in this study and treated with a test article.
  17. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

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): NCT02742441


Locations
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United States, Arkansas
Site 14
Fort Smith, Arkansas, United States, 72916
Site 01
Hot Springs, Arkansas, United States, 71913
United States, California
Site 17
Encino, California, United States, 91436
United States, Colorado
Site 19
Denver, Colorado, United States, 80220
United States, Florida
Site 16
Brandon, Florida, United States, 33511
Site 15
Clearwater, Florida, United States, 33756
Site 20
Miami Lakes, Florida, United States, 33014
Site 11
North Miami Beach, Florida, United States, 33162
Site 12
Pinellas Park, Florida, United States, 33781
United States, Indiana
Site 10
Carmel, Indiana, United States, 46032
Site 06
New Albany, Indiana, United States, 47150
United States, Massachusetts
Site 13
Quincy, Massachusetts, United States, 02169
United States, Michigan
Site 07
Ann Arbor, Michigan, United States, 48103
United States, Missouri
Site 02
Saint Joseph, Missouri, United States, 64506
United States, North Carolina
Site 08
Wilmington, North Carolina, United States, 28405
United States, Ohio
Site 04
Gahanna, Ohio, United States, 43230
United States, Tennessee
Site 05
Nashville, Tennessee, United States, 37215
United States, Texas
Site 09
Austin, Texas, United States, 78746
Site 18
San Antonio, Texas, United States, 78229
United States, Virginia
Site 21
Norfolk, Virginia, United States, 23507
United States, Washington
Site 03
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Therapeutics, Inc.:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02742441     History of Changes
Other Study ID Numbers: 122-0551-310
First Posted: April 19, 2016    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases