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A randomized, open-label, vehicle-controlled, parallel-cohort, dose-ranging study to explore the pharmacodynamics of topically applied imiquimod in healthy volunteers

Primary objective- To explore the pharmacodynamic effects of topically applied IMQ (in combination with or without TS) - To identify dose-response relationship of topically applied IMQ Secondary objective- To assess safety and tolerability of…

Markers of Efficacy of Xolair (Omalizumab) in Chronic Spontaneous Urticaria

To relate the reduction of inflammatory characteristics in skin and in peripheral blood to clinical efficacy in patients with CSU. Major focusses of this study are the (early) effects on basophils and other Fc*RI-bearing leukocytes before, during,…

An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisa
(SD-101-6.0) in Patients with Epidermolysis Bullosa

The aim is to assess the long-term safety of topical use of ZORBLISA in patients with Epidermolysis Bullosa (EB).

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

n.v.t.

DenovoDerm phase I. A phase I, open, prospective, multicentric study to evaluate the safety of autologous tissue-engineered dermal substitutes for the treatment of large deep-partial and full-thickness skin defects

To evaluate the safety of an autologous cellular collagen hydrogel-based skin graft (denovoDerm) in patients with skin defects that require definitive therapeutic coverage. DenovoDerm can be transplanted together with an STSG to cover a full…

Lipohypertrophy and endermotherapy®
Effect of endermotherapy® treatment in insulin induced lipohypertrophy in type 1 and 2 Diabetes Mellitus patients.

Primary objective;Change in section and extent of treated LH after treatment with endermotherapy® and without treatment. Change in resistance and pain during injection at the right and left LH and changes in appearance aspects of LH right and left.…

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…

Efficacy of a novel compound in a humanized mouse model of psoriasis

ln this study the effect of 1 novel compound on the development of psoriasis in the humanized mouse model isinvestigated.

Effects of bosentan in a homogeneous population of SSc subjects with a predefined restriction of blood flow in the hands

The primary objectives are:- To demonstrate the relationship of blood flow in the hands and the extent of digital ulcera in patients with systemic scleroderma;- Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks…

efficacy of barrier cream with or without Honeyin intergtrigo

Correcting the causative factors of intertrigo is critical. Take steps to eliminate friction, heat, and maceration by keeping folds cool and dry. The goals of pharmacotherapy for intertrigo are to reduce morbidity and to prevent complications. To…

Detection and evaluation of antibody formation against biologics in psoriasis

We would like to know to what extent psoriasis patients develop antibodies against biologics and what the clinical consequences of these antibodies are in routine practice.

An independent prospective randomised controlled trial comparing the efficacy and cost effectiveness of infliximab and etanercept in 'high need' patients with moderate to severe chronic plaque type psoriasis

What is the incremental cost effectiveness ratio of the use of etanercept versus infliximab?Are there subgroups of which infliximab or etanercept is more or less cost-effective in daily practice?Primary objectives: 1. To compare clinical efficacy of…

Comfort and Safety Study of Electrical Stimulation in Prevention of Decubitus

The primary objectives of this study are: 1. Will there be any adverse events, due to the electrical stimulation?2. Are the sock and the electrical stimulation comfortable for the patient?

Single-port thoracoscopic sympathicotomy for treatment of complex regional pain syndrome type I, a feasibility study.

The effect of the intervention on pain an regain of function in de affected extremity. This will be quantified in multiple questionnaires at baseline and three follow-up points, and by clinical evaulation of the hand function at baseline and two…

Efficacy of a novel compound in a humanized mouse model of psoriasis

ln this study the effect of 1 novel compound on the development of psoriasis in the humanized mouse model isinvestigated. The efficacy is compared to two registered drugs, namely Infliximab en Tociluzimab.

Phase I , single-center, open-label, two-period study to investigate the pharmacokinetics of the DMF-containing formulation FP187-GC in healthy volunteers after oral administration in fasted and fed state

Primary objective* To investigate the plasma pharmacokinetics of the first metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of the delayed- and slow-release FP187-GC tablet formulation after single dose…

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.

Pit Excision with Phenolisation of the Sinus Tract vs. Radical Excision in Sacrococcygeal Pilonidal Sinus Disease; A Randomised Controlled Trial

The objective of this study is to show that excision of the pit of the sinus of SPSD with phenolisation of the sinus tract is accompanied with sooner return to normal daily activities compared to local excision of the sinus with only a small…

Unrelated cord blood transplantation after reduced toxicity conditioning with mesenchymal stromal cell co-infusion in patients with severe epidermolysis bullosa

We propose a phase II study (intervention) in patients with severe generalized recessive dystrophic EB receiving reduced toxicity conditioning chemotherapy followe by cord blood transplantation with co-infusion of mesenchymal stromal cell units.…