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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02367911
Other study ID # 122-0551-305
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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