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

Plaque Psoriasis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882647
• Other study ID #: 000-0551-305
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2013
• Last updated: May 11, 2015
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• Source: Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• 000-0551 Lotion

• Vehicle Lotion

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	DermResearch, Inc.	Austin	Texas
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	MOORE Clinical Research, Inc.	Brandon	Florida
United States	The Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Florida Academic Dermatology Center	Miami	Florida
United States	Park Avenue Dermatology, PA	Orange Park	Florida
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana

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" at Day 8	Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.	Day 8	No
Other	Proportion of subjects rated a "treatment success" for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8	Interim analysis of clinical signs of psoriasis. "Treatment success" and clinical signs as defined in the secondary outcome measure.	Day 8	No
Other	Change from Baseline in pruritus score at 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).	Baseline and Day 15	No
Other	Change in % body surface area (BSA) with active psoriasis at Days 8 and 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.	Baseline, Day 8 and Day 15	No
Primary	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	No
Secondary	Proportion 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	No