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A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)

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ClinicalTrials.gov Identifier: NCT02368210
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Brief Summary:
This Phase 3 study (Study 306) 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 : 151 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 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : February 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
Drug: 122-0551 Foam
Topical Foam

Placebo Comparator: Vehicle Foam
Vehicle Foam, topically applied twice daily
Drug: Vehicle Foam
Topical Foam




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 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. 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" [ Time Frame: Day 8 ]
    "Treatment success" and IGA as defined in the primary outcome measure. "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).

  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 ]
    "Treatment success" and clinical signs as defined in the secondary outcome measure. "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).

  3. Change From Baseline in Pruritus Score [ 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 [ Time Frame: Baseline 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.



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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 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.
  • 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.

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): NCT02368210


Locations
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United States, California
Center for Dermatology Clinical Research
Fremont, California, United States, 94538
United States, Florida
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, Tennessee
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States, 37917
United States, Texas
The Center for Skin Research
Houston, Texas, United States, 77056
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Therapeutics, Inc.
Investigators
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Study Director: Anthony Andrasfay 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: NCT02368210    
Other Study ID Numbers: 122-0551-306
First Posted: February 23, 2015    Key Record Dates
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases