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A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis

2019-09-12 02:34:42 | BioPortfolio

Summary

Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" [RLD]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.

Study Design

Conditions

Plaque Psoriasis

Intervention

188-0551 Spray, RLD

Status

Not yet recruiting

Source

Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-12T02:34:42-0400

Clinical Trials [1252 Associated Clinical Trials listed on BioPortfolio]

Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)

This Phase 3 study (Study 307) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects w...

A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis

This Phase 3 study (Study 305) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects w...

A Comparison of 188-0551 Solution Versus Vehicle Solution in Subjects With Plaque Psoriasis (Study 203)

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A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis

The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis

Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis

This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05...

PubMed Articles [1092 Associated PubMed Articles listed on BioPortfolio]

Antistreptococcal interventions for guttate and chronic plaque psoriasis.

Psoriasis is a chronic skin disease that affects approximately two per cent of the general population. Plaque psoriasis is the most common form: it usually appears as raised, red patches of inflamed s...

Treatment of plaque psoriasis with IL-23p19 blockers: A systematic review and meta-analysis.

Interleukin(IL)-23 is a key cytokine in the pathogenesis of psoriasis, this meta-analysis was to analyze the efficacy and safety of IL-23p19 blockers in patients with plaque psoriasis.

Association of Biologic Therapy With Coronary Inflammation in Patients With Psoriasis as Assessed by Perivascular Fat Attenuation Index.

Psoriasis is a chronic inflammatory skin disease associated with increased coronary plaque burden and cardiovascular events. Biologic therapy for psoriasis has been found to be favorably associated wi...

Sustained Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Severe Chronic Plaque Psoriasis from a Randomised, Double-Blind, Phase 3 Study.

Adalimumab (Humira , AbbVie Inc, USA) is EMA approved for children ages ≥4 years with severe plaque-psoriasis.

Successful Treatment of Refractory Plaque-Type Psoriasis and Psoriatic Arthritis With Guselkumab and Adalimumab Combination Therapy: A Case Report

Copy: A number of biologics have been approved for use in plaque-type psoriasis. They act by either blocking the action of a specific type of cell or protein in the immune system. Case presentation: ...

Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

Endovascular procedure in which atheromatous plaque is excised by a cutting or rotating catheter. It differs from balloon and laser angioplasty procedures which enlarge vessels by dilation but frequently do not remove much plaque. If the plaque is removed by surgical excision under general anesthesia rather than by an endovascular procedure through a catheter, it is called ENDARTERECTOMY.

The term applied to a group of relatively uncommon inflammatory, maculopapular, scaly eruptions of unknown etiology and resistant to conventional treatment. Eruptions are both psoriatic and lichenoid in appearance, but the diseases are distinct from psoriasis, lichen planus, or other recognized dermatoses. Proposed nomenclature divides parapsoriasis into two distinct subgroups, PITYRIASIS LICHENOIDES and parapsoriasis en plaques (small- and large-plaque parapsoriasis).

A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

An index which scores the degree of dental plaque accumulation.

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