Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis...
PsoriasisA randomised, double-blind, placebo-controlled, trial to evaluate the efficacy of brodalumab monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with moderate-to-severe plaque-type psoriasis who are candidates for systemic therapy
Exploratory Study to Evaluate the Application of NLAC Cream in Adults With Plaque Psoriasis
Plaque PsoriasisPsoriasis is a chronic and immune mediated skin disorder that presents with plaques of thickened, scaly skin. Up to 71% patients suffer from psoriasis, leading to high impact on their daily life. Plaque psoriasis is the most common type which causes thick, scaly patches of skin. Although the treatment of moderate-to-severe psoriasis has been improved with the new launched biologics, topical therapies continue to play a key role in the management of mild-to-moderate psoriasis. Up to 80% of patients of psoriasis use topical agents as their first-line therapy, including topical vitamin D analogs, corticosteroids, vitamin A analogs, and anthralin. There are well-documented concerns and limitations with current topical treatments. In this study, we propose a nature lactic acid enriched cream with a high safety profile as an alternative choice for patients with plaque psoriasis. Lactic acid is a natural moisturizing factor, which exists in healthy skin. It can efficiently prevent water loss from the skin and alleviate allergic reactions caused by dry skin. The moisturized function of lactic acid has made it became a commonly used additive in a wide variety of skincare products, such as lotion, cream, butter and spray. This product is rich in natural lactic acid generated by the fermentation of probiotics, and therefore can relieve skin itching caused by skin dryness, and resume the water-holding capability of the skin by removing abnormally proliferative stratum corneum as well as inducing collagen production. Importantly, this product is a steroid-free product with safety and without any induced adverse effects in use. This product is also can be a promising option other than steroids to be applied for the mitigation of recurrent symptoms in plaque psoriasis by resuming the water-retention ability of skin and rebuilding skin barrier function.
Predicting Medication Response for Autoimmune Disease
Ulcerative ColitisCrohn's Disease2 moreCoral is conducting a large study comparing and predicting the relative effectiveness of different medications for autoimmune patients. Patients with Inflammatory Bowel Disease (IBD) who have been diagnosed with either Ulcerative Colitis or Crohn's Disease and are undergoing treatment are eligible to participate. Patients with Rheumatoid Arthritis (RA) and Psoriasis (Ps) will also be enrolled. A novel clinical test will be performed to predict the responsiveness of a particular patient to different immune modulating therapies used in these conditions.
SystemIc iNflammation and Microvascular diSease PreventIon in psoRiatic diseasE
PsoriasisPsoriatic Arthritis1 moreThis is a single-label open-arm mechanistic clinical study recruiting patients with psoriasis or psoriatic arthritis with elevated cardiovascular risk. Subjects enrolled in this study will receive statin treatment with rosuvastatin. The statin treatment in this study will be used as an intervention with widely known pleiotropic CV risk reduction effects, including anti-inflammatory reduction. Subjects will be studied before statin therapy and followed for 48 weeks on treatment. The primary outcome will be change in the coronary flow reserve (CFR) as measured by cardiac PET. Overall, this study will examine the impact of statin therapy on changes in CFR as a reflection of impaired coronary vasoreactivity and a manifestation of myocardial ischemia, which may precede clinical CV events (and visible changes in plaque morphology) in high-risk patients with psoriatic disease.
Randomized, Double Blinded, Placebo Controlled, Single Dose Escalation Study of 608 in Healthy Subjects...
Moderate to Severe Plaque PsoriasisThis is a first-in-human, phase 1, single-center, randomized, double blinded, placebo-controlled, single dose-escalation study to evaluate the safety, tolerability, PK, of 608 following subcutaneous injection in healthy subjects.
Laser-assisted Topical Administration of Etanercept (Enbrel®) in Patients With Mild to Moderate...
Psoriatic PlaqueThe purpose of this study is to assess the feasibility and safety of topical administration of etanercept via AFL micropores to psoriatic plaques in patients with mild to moderate plaque-type psoriasis. While a wide variety of therapeutic innovations to treat moderate-to-severe psoriasis (accounting for around 30% of the cases) become available each year, there are few innovations for topical therapies to treat mild/localized psoriasis (accounting for around 70% of the cases). Given that only about half of the patients respond adequately to the current standard of care, the topical application of a fixed combination of calcipotriole and betamethasone, there is a medical need for better topical therapies. Etanercept has been used successfully to treat moderate-to-severe plaque-type psoriasis in children and adults for more than a decade. Its standard route of application is through subcutaneous injections. Different dosing regimens have been used: 1 x 50 mg or 2 x 50 mg per week as well as 1 x 25 mg or 2 x 25 mg per week. Under these regimens, etanercept has a well-established favorable long-term safety record, with injection site reactions (pain, swelling) the most frequently reported side effects. However, rare but serious side effects such as serious opportunistic infections resulting from immune system inhibition common to anti-TNF agents limit its systemic use to these patients. For this reason, a localized topical alternative route of administration would be desirable. However, the large molecular size and chemical nature of etanercept prevent it from crossing the epidermal barrier. A CE certified ablative fractional laser (AFL) device with Er:YAG source will be used to create micropores in plaques to allow local delivery of etanercept directly into psoriatic plaques.
Cell Responses to IFN-gamma
Plaque PsoriasisIFN-gamma is a central player in the development of psoriasis lesions, which can be involved a variety of cellular processes in the skin. Dendritic cells are important cells in driving inflammation in psoriasis through the induction of T cells that produce IL-17 in psoriasis. Injecting IFN-g into the skin can increase the numbers of T cells and also inflammatory DCs that produce cytokines involved in IL-17 production. Thus, the investigators hypothesize that the dendritic cells present in the skin after IFN-g injection polarize IL-17-producing T cells.
Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis...
Moderate to Severe PsoriasisAdalimumab has recently been authorized for active psoriasis in Peru and local experience is very low. The aim of this study is to obtain Peruvian data of clinical effectiveness and impact on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis complying with the dosing and monitoring recommendations of the local approved label.
Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis...
Fingernail PsoriasisThe purpose of this clinical study is to compare the efficacy and safety of three concentrations of topical methotrexate for the treatment of fingernail psoriasis.
Fumaric Acid Ester-PUVA Therapy Versus Acitretin -PUVA Therapy in Pustular Palmoplantar Psoriasis...
Pustular Palmoplantar PsoriasisThe purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with pustular palmoplantar psoriasis. Patients will be randomized and allocated in concealed manner to one of the two treatment arms: acitretin-PUVA or FAE-PUVA.