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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
000-0551 Lotion
Vehicle Lotion
Sponsored by
Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring psoriasis, lotion, investigator's global assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Total Skin and Beauty Dermatology Center, PC
  • MOORE Clinical Research, Inc.
  • Florida Academic Dermatology Center
  • Park Avenue Dermatology, PA
  • The Indiana Clinical Trials Center, PC
  • Hamzavi Dermatology
  • The Psoriasis Treatment Center of Central New Jersey
  • Academic Dermatology Associates
  • Academic Dermatology Associates
  • Arlington Research Center, Inc.
  • DermResearch, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Arm

Vehicle Arm

Arm Description

Topical lotion, applied twice daily

Topical lotion, applied twice daily

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 18, 2013
Last Updated
December 20, 2016
Sponsor
Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01882647
Brief Title
A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
psoriasis, lotion, investigator's global assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Arm
Arm Type
Experimental
Arm Description
Topical lotion, applied twice daily
Arm Title
Vehicle Arm
Arm Type
Placebo Comparator
Arm Description
Topical lotion, applied twice daily
Intervention Type
Drug
Intervention Name(s)
000-0551 Lotion
Intervention Type
Drug
Intervention Name(s)
Vehicle Lotion
Primary Outcome Measure Information:
Title
The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Description
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).
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
The Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Description
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).
Time Frame
Day 15
Other Pre-specified Outcome Measures:
Title
Percentage of Subjects With IGA "Treatment Success" at Day 8
Description
Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.
Time Frame
Day 8
Title
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8
Description
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.
Time Frame
Day 8
Title
Change From Baseline in Pruritus Score at Day 15
Description
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).
Time Frame
Baseline and Day 15
Title
Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15
Description
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.
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syd Dromgoole, Ph.D.
Organizational Affiliation
Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
MOORE Clinical Research, Inc.
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Florida Academic Dermatology Center
City
Miami
State/Province
Florida
Country
United States
Facility Name
Park Avenue Dermatology, PA
City
Orange Park
State/Province
Florida
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
Country
United States
Facility Name
The Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Arlington Research Center, Inc.
City
Arlington
State/Province
Texas
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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