A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)

NCT01871402 | Completed Phase 3 Results

• 1 other identifier: 000-0551-304
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 10

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.

Conditions

Plaque Psoriasis

Keywords

psoriasis; lotion; investigator's global assessment

Outcome Measures

Primary Outcomes (1)

• Proportion 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).

  Day 15

Secondary Outcomes (1)

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

  Day 15

Other Outcomes (4)

• Proportion of Subjects With IGA "Treatment Success" at Day 8

  Day 8

• Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis at Day 8

  Day 8

• Change From Baseline in Pruritus Score at Day 15

  Baseline and Day 15

Study Arms (2)

Active Arm

EXPERIMENTAL

Topical lotion, applied twice daily

Drug: 000-0551 Lotion

Vehicle Arm

PLACEBO COMPARATOR

Topical lotion, applied twice daily

Drug: Vehicle Lotion

Interventions

000-0551 Lotion DRUG

Active Arm

Vehicle Lotion DRUG

Vehicle Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (10)

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Location

UCSD Dermatology

San Diego, California, United States

Location

Altman Dermatology Associates

Arlington Heights, Illinois, United States

Location

Henry Ford Health System

Detroit, Michigan, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Location

Oregon Medical Research Center, PC

Portland, Oregon, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, United States

Location

Research Across America

Dallas, Texas, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Research, Therapeutics, Inc.
• Organization: Therapeutics, Inc.

clinicalresearch@therapeuticsinc.com

858-571-1800

Study Officials

• Syd Dromgoole, Ph.D.

  Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 13, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-04

Locations

US (10)