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Epigenetic biomarkers to predict psoriasis disease progression * towards tailored therapy.

Primary Objective: To define a top set of genes that most reliably (r >=0.95) distinguish psoriasis from normal skin. We will define this set from differential methylation genes to indicate potential biomarkers.Secondary Objective(s):…

Efficacy of Verapamil/ Verapamil-Kenacort injection versus Kenacort injection in Scar Treatment

Scar volume and POSAS score will be measured in the Verapamil group, these will be compared to the scar volume and POSAS score in the Kenacort+Verapamil group and the Kenacort group. In addition, complications/ adverse effects will be reported.

Genes involved in the induction and resolution of eczema using the Atopy Patch Test as an in vivo model for atopic dermatitis

To investigate biomarkers that play a role in the induction and resolution of AD.Secondary objective: to develop therapeutic interventions (pharmacologically) based on the revealed biomarkers.

Antibiotic prophylaxis and prevention of wound infections following implant removal after foot, ankle and lower leg fractures

In light of the above, our objective is to study the (cost-) effectiveness of a single intravenous gift of antibiotic prophylaxis with a firstgeneration cephalosporin prior to implant removal following surgical fixation of foot, ankle and/or lower…

A phase III, randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in autoinjectors, to demonstrate efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 3 years in subjects with active Psoriatic Arthritis (CAIN457F2318)

Primary: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebo based on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- PASI75 week 24- PASI90 week 24-…

Limberg-flap versus primary closure in the midline after primary excision of a pilonidal sinus

n.v.t.

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.

INTENT: immunogenicity in patients failing response on anti-TNF
- phase 1: immunogenicity and pharmacokinetics in patients failing to respond to TNF inhibitors.
- phase 2: clinical effectiveness of subsequent TNF inhibitor treatment and predictive value of pharmacokinetics and immunogenicity.

1. To determine the proportion of patients developing anti-drug antibodies (ADA) detectable with an antigen binding test (ABT, radioimmunoassay) in patients experiencing inefficacy of their first TNF inhibitor treatment (phase 1).2. To study…

The DANCE study: Duration of ANtibiotic therapy for CEllulitis

To determine if 6 days of antibiotics has equal efficacy compared to 12 days for patients hospitalized with cellulitis.

A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa

The primary objective is to compare the efficacy and safety of SD-101-6.0vs. SD- 101-0.0 (placebo) in patients with Simplex, RecessiveDystrophic, or Junctional non Herlitz Epidermolysis Bullosa.The primary endpoint is the complete closure of the…

A double blind randomized controlled trial comparing the efficacy of 7% lidocaine / 7% tetracaine cream versus 2,5% lidocaine / 2,5% prilocaine cream for local anaesthesia during laser treatment of acne keloidalis nuchae and tattoo removal.

To compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.

A randomized, double-blind, placebo-controlled study to demonstrate the efficacy and long-term safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis.

Primary objective:To demonstrate the efficacy of dupilumab administered concomitantly with TCS through week 16 in adult patients with moderate-to-severe atopic dermatitis (AD).Secondary objectives:Evaluate long-term efficacy of dupilumab when…

Fractional CO2 laser assisted topical articaine anesthesia vs. topical EMLA administration: a randomized controlled study

The objective of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution compared to standard anesthesia with topical eutectic mixture of…

Is lowering of shear and friction (cost)effective for prevention of pressure ulcers? A multicenter, prospective, controlled randomized clinical trial in Dutch nursing homes.

Analyze whether application of a theoretical reasoned and tested system with test subjects is preventive and costs effective.

Evaluation of the use of biomarker levels in dried blood spots as a measurement tool for disease severity in patients with atopic dermatitis (AD) and psoriasis.

to investigate whether the levels of a panel of biomarkers in dried blood spots can be used as a disease severity measurement tool in patients with AD, treated with topical steroids.

The effect of BS6.890C in the prophylactic transplant model of
psoriasis in which a psoriatic lesion is induced in non-lesional skin
transplanted onto immune-deficient (BNX) mice by injecting superantigen
activated peripheral blood cells intra-dermally into the
transplant.

The aim of the project is to test BS6.890C in the prophylactic transplant model of psoriasis.

A phase I/IIa open-label First-in-Human study to assess safety and pharmacokinetics and explore biomarker effects of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in subjects with cutaneous warts.

Primary objectives• To evaluate the systemic exposure of digoxin and furosemide after repeated topical CLS003 application in otherwise healthy subjects with multiple cutaneous warts;• To assess the safety/tolerability profile of CLS003.Secondary…

Development and validation of a humanized mouse psoriasis model to be applied for efficacy analysis of novel therapeutic compounds

In this study the material of 6 donors is used to develop and validate a humanized psoriasis model in mice. Also, the team of TNO Triskelion will be trained.

A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Efficacy and Safety of Topical Ionic Contra-viral Therapy (ICVT) Comprised of Digoxin and Furosemide in Cutaneous Warts

Primary objective: • To assess efficacy of CLS003 in reduction of wart area after six weeks of treatment when applied to cutaneous warts (common or plantar)• To evaluate the activity of the ionic contra-viral therapy CLS003, in a HPV biomarker after…

A study of skin responses to histamine

The primary objective of this study is to detect significant difference in the average response to histamine, topically and iontophoretically applied to the skin, between sensitive and non-sensitive skin volunteers. Skin reactions are assessed with…