Psoriasis

About Psoriasis Clinical Trials (Click to Open)

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Psoriasis

General Purpose:

Under normal circumstances, skin cells form in the deep layers of skin and rise to the top layer approximately once per month. In psoriasis, this process occurs faster than normal, causing dead skin cells to accumulate on the surface of the skin. The result is irritated, thick, red skin that is accompanied by areas of flaky, silver patches called scales.

Although anyone can get psoriasis, it most often occurs for the first time in individuals between the ages of 15 and 35. Fortunately, it is not contagious and cannot be spread between individuals. Research suggests that it is hereditary in nature and is passed down through families.

Most researchers believe that it is also a disease of the immune system, and likely occurs when the body’s immune system mistakenly attacks healthy cells. Triggers such as infection, dry air, injury, certain medications, stress, too much or too little sunlight, and too much alcohol can cause psoriasis to flare-up in predisposed individuals.

Furthermore, individuals with weakened immune systems – as a result of AIDS, certain autoimmune diseases (such as rheumatoid arthritis or lupus), or chemotherapy treatment for cancer – may experience more severe cases of psoriasis than those whose immune systems are not compromised.

Researchers are hard at work working to better understand the nature of psoriasis, develop methods to prevent flare-ups, and improve existing treatment.

What Will Psoriasis Clinical Trials Be Like?

The types of procedures used in psoriasis clinical trials will ultimately depend on the specific nature of the study and what aspect of psoriasis is being studied. Provided below is a list of common procedures, tests, and assessments that may be incorporated into psoriasis clinical trials:

  • Detailed physical examination
  • A questionnaire or face-to-face interview to provide details related to your history of psoriasis, which may include questions related to the following:
    • Date you first developed psoriasis
    • Noticeable triggers
    • Use of cosmetic and personal hygiene products
    • Family history of psoriasis
    • Use of prescription or over-the-counter medications, including vitamins, minerals, and other dietary supplements
    • Treatments you have attempted to use for your psoriasis
    • You may also be asked to avoid wearing lotions, perfumes, colognes, or scented make-up on the day(s) of your appointment.
    • Questionnaires to evaluate your stress level and/or emotional well-being.
    • Blood tests
    • Skin biopsy
    • Photographs of your skin
    • Use of lotions, creams, oral medications, or laser light therapy.

Typical Psoriasis Clinical Trial Protocol:

Specific examples of clinical trials for psoriasis might include the following:

  • A study in which 100 patients with psoriasis and 100 healthy controls provide blood samples for analysis to determine their lipid levels (cholesterol, triglycerides), blood sugar levels, and certain blood chemicals related to an increased risk of cardiovascular disease. The participants would then be followed over regular intervals for a two year period to determine if 1) psoriasis patients are more likely to develop cardiovascular disease than those without psoriasis; and 2) if the severity of psoriasis corresponds to increased lipids, blood sugar, and other measured factors.
  • A study to determine if specific dietary changes (e.g., elimination of dairy, increased intake of fiber) are effective at reducing psoriasis flare-ups.
  • A study to determine if laser light therapy is a safe and effective means of treating severe psoriasis. In this study, patients would be randomly assigned to receive either treatment with the laser light or a “placebo” treatment during which laser light therapy is simulated but not actively delivered. 
  • A randomized clinical trial in which individuals with psoriasis are randomly assigned to receive a newly developed drug to treat psoriasis in addition to standard therapy, or to receive standard therapy plus a placebo.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the fourth example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated (such as the third clinical trial example described above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your history of treatment for psoriasis
  • Your prior and current diagnoses of any other health conditions or diseases
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms:

 “psoriasis treatment,” “psoriasis children,” “psoriasis diet,” “psoriasis complications,” “psoriasis scar,” “psoriasis arthritis,” “psoriasis cardiovascular disease,” “psoriasis triggers,” and “psoriasis medication.”

 

 

 

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Safety and Efficacy of Secukinumab in Mild Psoriasis


Condition:   Psoriasis
Interventions:   Drug: Secukinumab;   Drug: Placebo followed by Secukinumab
Sponsors:   James G. Krueger, MD, PhD;   Novartis
Recruiting - verified May 2017


Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis


Condition:   Psoriasis
Interventions:   Drug: NP000888;   Drug: Vehicle
Sponsor:   Galderma R&D
Recruiting - verified April 2017


BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test


Condition:   Psoriasis
Interventions:   Drug: BAY1003803;   Drug: Clobetasol propionate;   Drug: Betamethasone/calcipotriene
Sponsor:   Bayer
Completed - verified March 2017


LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris


Condition:   Psoriasis Vulgaris
Interventions:   Drug: LEO 32731;   Drug: LEO 32731 Placebo
Sponsor:   LEO Pharma
Active, not recruiting - verified March 2017


The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis


Condition:   Psoriasis
Interventions:   Drug: Riboflavin;   Other: Placebo
Sponsor:   University of Michigan
Recruiting - verified January 2017


Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis


Condition:   Nail Psoriasis
Interventions:   Drug: P-3073;   Drug: Vehicle of P-3073
Sponsor:   Polichem S.A.
Completed - verified May 2017


The Corrona Psoriasis Registry


Condition:   Psoriasis
Intervention:  
Sponsor:   Corrona, LLC.
Enrolling by invitation - verified April 2017


Serum, Cellular and Imaging Markers of Arthritis in Psoriasis Patients


Condition:   Psoriasis
Intervention:  
Sponsors:   University of Rochester;   Rheumatology Research Foundation
Active, not recruiting - verified March 2017


Plaque Psoriasis Efficacy and Safety With Secukinumab


Condition:   Plaque Psoriasis
Intervention:   Biological: Secukinumab
Sponsor:   Novartis Pharmaceuticals
Active, not recruiting - verified August 2016


Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis


Condition:   Psoriasis
Intervention:  
Sponsors:   Northwestern University;   AbbVie
Recruiting - verified September 2016


DFD06 Cream vs Comp01 Cream HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis


Condition:   Psoriasis
Interventions:   Drug: DFD06 Cream;   Drug: Comp01
Sponsor:   Promius Pharma, LLC
Completed - verified September 2016


Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis


Condition:   Psoriasis
Interventions:   Biological: Adalimumab;   Biological: ABP 501
Sponsor:   Amgen
Completed - verified October 2016


Secukinumab in TNF-IR Psoriasis Patients.


Condition:   Psoriasis
Interventions:   Biological: Secukinumab 150 mg;   Biological: Secukinumab 300 mg
Sponsor:   Novartis Pharmaceuticals
Completed - verified February 2017


Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)


Condition:   Psoriasis
Intervention:   Biological: Secukinumab
Sponsor:   Novartis Pharmaceuticals
Completed - verified August 2016


Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.


Condition:   Psoriasis
Intervention:   Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
Sponsors:   University of North Carolina, Chapel Hill;   AbbVie
Completed - verified October 2016


AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis


Condition:   Psoriasis
Interventions:   Drug: AN2728 ointment, 2%;   Drug: Ointment Vehicle
Sponsor:   Pfizer
Completed - verified March 2017


The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis


Condition:   Psoriasis
Interventions:   Drug: Calcipotriene Foam;   Drug: Vehicle Foam
Sponsors:   Stiefel, a GSK Company;   GlaxoSmithKline
Completed - verified November 2016


Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis


Condition:   Psoriasis
Interventions:   Drug: AN2728;   Drug: Placebo
Sponsor:   Pfizer
Completed - verified January 2017


Fluphenazine Hydrochloride for Psoriasis


Condition:   Psoriasis
Interventions:   Drug: Fluphenazine;   Drug: Placebo
Sponsors:   Tufts Medical Center;   Immune Control
Completed - verified March 2017


Developing A Validated Measure of the Impact of Psoriasis on Chronic Quality of Life


Condition:   Psoriasis
Intervention:  
Sponsor:   Massachusetts General Hospital
Completed - verified March 2017


Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis


Condition:   Psoriasis
Interventions:   Drug: AN2728;   Drug: AN2728 Ointment Vehicle
Sponsor:   Pfizer
Completed - verified January 2017


Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis


Condition:   Psoriasis
Interventions:   Drug: AN2728;   Drug: Ointment vehicle
Sponsor:   Pfizer
Completed - verified January 2017


Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies


Condition:   Psoriasis
Interventions:   Drug: U0267;   Drug: Vehicle
Sponsors:   Stiefel, a GSK Company;   GlaxoSmithKline
Completed - verified November 2016


Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies


Condition:   Psoriasis
Interventions:   Drug: U0267 Foam;   Drug: Vehicle foam
Sponsors:   Stiefel, a GSK Company;   GlaxoSmithKline
Completed - verified August 2016


Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis


Condition:   Psoriasis
Intervention:   Drug: CC10004
Sponsor:   Celgene Corporation
Completed - verified November 2016

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