A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: 122-0551 Foam; Drug: Vehicle Foam

• Registration Number: NCT02367911
• Lead Sponsor: Therapeutics, Inc.

Brief Summary

This Phase 3 study 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Primary Completion: 2015-08
• Study Completion: 2017-02
• Disposition First Submitted: 2017-02-16
• Disposition First Submitted QC: 2017-02-16
• Disposition First Posted: 2017-02-17
• Results First Submitted: 2018-08-30
• Results First Submitted QC: 2018-08-30
• Results First Posted: 2018-09-27
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Arm	122-0551 Foam	122-0551 Foam, topically applied twice daily for two weeks
Vehicle Arm	Vehicle Foam	Vehicle Foam, topically applied twice daily for two weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)	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).

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Total Skin and Beauty Dermatology Center, PC; 🇺🇸 Birmingham, Alabama, United States

UCSD Dermatology; 🇺🇸 San Diego, California, United States

Leavitt Medical Associates of Florida d/b/a Ameriderm Research; 🇺🇸 Ormond Beach, Florida, United States

Shideler Clinical Research Center; 🇺🇸 Carmel, Indiana, United States

The Indiana Clinical Trials Center, PC; 🇺🇸 Plainfield, Indiana, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

MediSearch Clinical Trials; 🇺🇸 Saint Joseph, Missouri, United States

Dermatology Consulting Services; 🇺🇸 High Point, North Carolina, United States

Arlington Research Center, Inc.; 🇺🇸 Arlington, Texas, United States