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

Plaque Psoriasis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367911
• Other study ID #: 122-0551-305
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2018
• Source: Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: February 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• 122-0551 Foam
122-0551 Foam applied twice daily to treat psoriasis
• Vehicle Foam
Vehicle Foam applied twice daily to treat psoriasis

Locations

Country	Name	City	State
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	Henry Ford Health System	Detroit	Michigan
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Leavitt Medical Associates of Florida d/b/a Ameriderm Research	Ormond Beach	Florida
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	UCSD Dermatology	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Subjects With IGA "Treatment Success"	"Treatment success" and IGA as defined in the primary outcome measure.	Day 8
Other	Proportion of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)	"Treatment success" and clinical signs as defined in the secondary outcome measure.	Day 8
Other	Change From Baseline in Pruritus Score	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).	Day 15
Other	Change in % Body Surface Area (BSA) With Active Psoriasis	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.	Day 8 and Day 15
Primary	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).	Day 15
Secondary	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).	Day 15