A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)

• ClinicalTrials.gov Identifier: NCT02368210
• Recruitment Status: Completed
• First Posted: February 23, 2015
• Results First Posted: November 26, 2018
• Last Update Posted: November 26, 2018
• Sponsor: Therapeutics, Inc.
• Information provided by (Responsible Party): Therapeutics, Inc.

Study Description

Brief Summary:

This Phase 3 study (Study 306) 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.

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: 122-0551 Foam; Drug: Vehicle Foam	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
• Study Start Date: January 2015
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: February 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 122-0551 Foam; 122-0511 Foam, topically applied twice daily	Drug: 122-0551 Foam; Topical Foam
Placebo Comparator: Vehicle Foam; Vehicle Foam, topically applied twice daily	Drug: Vehicle Foam; Topical Foam

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) [ Time Frame: 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/very severe).

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Percentage of Subjects With IGA "Treatment Success" [ Time Frame: Day 8 ]
   "Treatment success" and IGA as defined in the primary outcome measure. "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).
2. Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) [ Time Frame: Day 8 ]
   "Treatment success" and clinical signs as defined in the secondary outcome measure. "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).
3. Change From Baseline in Pruritus Score [ Time Frame: Baseline and 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).
4. Change in Percent Body Surface Area (BSA) With Active Psoriasis [ Time Frame: Baseline and Day 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.
• 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.

Contacts and Locations

Locations

United States, California

Center for Dermatology Clinical Research

Fremont, California, United States, 94538

United States, Florida

International Dermatology Research, Inc.

Miami, Florida, United States, 33144

United States, Illinois

Altman Dermatology Associates

Arlington Heights, Illinois, United States, 60005

United States, Minnesota

Minnesota Clinical Study Center

Fridley, Minnesota, United States, 55432

United States, New Mexico

Academic Dermatology Associates

Albuquerque, New Mexico, United States, 87106

United States, Tennessee

Dermatology Associates of Knoxville

Knoxville, Tennessee, United States, 37917

United States, Texas

The Center for Skin Research

Houston, Texas, United States, 77056

United States, Virginia

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Therapeutics, Inc.

Investigators

• Study Director: Anthony Andrasfay; Therapeutics, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bhatia N, Stein Gold L, Kircik LH, Schreiber R. Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis. J Drugs Dermatol. 2019 Aug 1;18(8):790-796.

• Responsible Party: Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02368210
• Other Study ID Numbers: 122-0551-306
• First Posted: February 23, 2015
• Results First Posted: November 26, 2018
• Last Update Posted: November 26, 2018
• Last Verified: October 2018

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases