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
Verified date | October 2018 |
Source | Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Therapeutics, Inc. |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01194219 -
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis
|
Phase 3 | |
Recruiting |
NCT06030076 -
A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
|
||
Completed |
NCT04263610 -
Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy
|
Phase 4 | |
Completed |
NCT02601469 -
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT05600036 -
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT05375955 -
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
|
Phase 2 | |
Completed |
NCT03614078 -
A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis
|
Phase 2 | |
Not yet recruiting |
NCT05036889 -
A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes.
|
N/A | |
Completed |
NCT04603027 -
A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT03638258 -
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT02881346 -
Efficacy and Tolerability of Enstilar® in Daily Practice
|
||
Recruiting |
NCT02611349 -
Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
|
Phase 3 | |
Completed |
NCT02251678 -
Evaluate the Effect of Elimune Capsules
|
Phase 1 | |
Completed |
NCT01987843 -
Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
|
Phase 2 | |
Terminated |
NCT01708629 -
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
|
Phase 3 | |
Completed |
NCT01230138 -
Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis
|
Phase 2 | |
Withdrawn |
NCT00747032 -
To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis
|
Phase 3 | |
Completed |
NCT00581100 -
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
|
Phase 4 | |
Suspended |
NCT01228656 -
Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate
|
Phase 2 | |
Completed |
NCT00540618 -
A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
|
Phase 2 |