Bei meiner laufenden Forschungstätigkeit geht es um die Umsetzung neuer medizinischer Errungenschaften in die Praxis der Therapie.

Nicht das was möglicherweise hilft,
sondern das, was wirkt, zählt!

Die Forschungen unterliegen strengster Kontrollen durch die U. S. Food and Drug Administration und das BfArM- Bundesinstitut für Arzneimittel und Medizinprodukte

 

Publikationen

 

Meffert,H.; Prés, H.; Diezel, W.; Sönnichsen, N.: Antipsoriatische und phototoxische Wirksamkeit von Hämatoporphyrin-Derivat nach topischer Applikation und Bestrahlung mit sichtbarem Licht. Dermatol. Mon.-schr. 175 (1989) 28-34

Prés, H.; Meffert, H.; Sönnichsen, N.: Photodynamische Therapie der Psoriasis palmaris et plantaris mit topisch applzietem Hämatoporphyrin-Derivat und sichtbarem Licht. Dermatol. Mon.-schr. 175 (1989) 745-750

Prés, H.; Meffert, H.; Barthelmes, H.; Klug, H.; Sönnichsen, N.: Perkutane Absorption von Hämatoporphyrin-Derivat - Fluoreszenz- und elektronenemikroskopische Untersuchungen. Dermatol. Mon.schr. 176 (1990) 461-468

Meyer, KG.; Prés, H.; Thielert, C.; Twafik, H. et al.: A Randomised, Double-Blind, Four-Arm Parallel-Group Phase II-Study to Investigate the Clinical Efficacy of Two Galenic Formulations of Polyphenon E in the Treatment of Genital Warts. Archives of Dermatology, in preparation

Decroix, J.; Prés, H.; Tzankov, N. et al.: Clobetasol Propionat Lotion in the Treatment of moderate to severe plaque-type Psoriasis. Cutis, in preparation

 

Im Folgenden informiere ich über die bisherigen Studien, an denen ich als Prüfarzt mitgewirkt habe

1992
systemic Cyclosporin A against severe Psoriasis, Phase IV, only Verum

1992
systemic Brivudin against Herpes simplex infection, Phase IV, only Verum

1993
Clotrimazol-Zinkoxid-Cream against intertriginous Mycosis, Phase III, versus Myko-Cordes-Plus-Paste

1993
Methylprednisolonaceponat-Milk against acute eccema, Phase II, versus Placebo

1993
Amorolfin-Varnish against Onychomycosis, Phase IV, versus Bifonazol-Set

1993
Bufexamac against acute eccema, Phase III, versus Placebo

1994
Amorolfin-Varnish in patients with trophic disarrangement and Onychomycosis, Phase IV, only Verum

1994
Methylprednisolonaceponat-Milk against acute eccema, Phase III, versus Amciderm-Lotio

1994
systemic Levofloxacin against Infections of Cutis/Subcutis, Phase III, versus Amoxicillin/Clavulansäure

1995
systemic Brivudin against Herpes zoster, dosisfinding, Phase II, placebo controlled, versus Acyclovir

1995
Laceran-Urea-Lotion 10% for childrens with Ichthyosis, Phase III, halfsite-controlled

1995
Ciclopirox-Shampoo against seborrhoic eccema, Phase II, versus Plazebo

1995
Brivudin-Hydrogel against Herpes simplex, Phase II, placebo controlled, versus Acyclovircreme

1996
systemic Synercid (Quinupristin/Dalfopristin) against complicate Skin-Infections, PhaseIII, versus Vancomycin or Cephazolin

1996
systemic Brivudin against Herpes zoster, Phase III, dosisfinding, versus Acyclovir

1997
5-Fluorouracil/Adrenalin-Gel for intralesional injection against Condylomata accuminata, Phase IV

1999
systemic Brivudin against Herpes zoster, respectivly postzosteric Neuralgia, Phase III, versus Famcyclovir

1999
0,05% Clobetasol-Propionat-Lotion against moderat to severe Plaques-Psoriasis, Phase III, versus Plazebo and
Dermovalcreme

2000
perileasional subcutaneous Injektion of rHuGM-CSF against venous Ulcera, Phase III, placebo-controlled

2000
0,05% Clobetasol-Propionat-Lotion against moderate to severe Plaques-Psoriasis, Phase III, versus Placebo and Dermoval-Creme

2000
Polyphenon E-Creme against Condylomata accuminata, Phase III, placebo-controlled

2001
systemic Levocetririzin for therapy of chronic idiopathic Urticaria, Phase III, placebo-controlled

2001
0,05% Clobetasol-Propionat-Shampoo against Scalp-Psoriasis, Phase III, versus Placebo und Dermovalgel

2001
Calcitriol-ointment for therapy of chronic Plaque-Psoriasis, Phase IV, safety in long-time-use
Phase IV

2002
Clindamycin-gel versus Clindamycin-solution for therapy of Acne vulgaris, Phase IV, placebo-controlled

2003
Polyphenon E Cream against Condylomata accuminata, Phase III, placebo-controlled

2003
Brivudincream versus Acyclovircream for therapy of Herpes labialis, Phase II

2003
systemic Rosiglitazon, dosisfinding, versus Placebo for therapy of chronic Plaque-Psoriasis, Phase III

2003
Terbinafin-film-Solution versus Vehicle-film-Solution against Tinea pedis, Phase III

2003
Terbinafin 1% cream as generic versus versus Original and Vehiclecream against Tinea pedis interdigitalis, Phase IV

2003
topical application of 0,1 % Ethacridinlactatl-solution versus Vehiclesolution for therapy of venous Ulcera cruris St I und II, Phase IV

2003
Pneumokokken-Konjugat-Vaccine versus Pneumokokken-Polysaccharid-Vaccine in Adults over 70 live-years, Phase I

2004
Terbinafincream 1% as generic versus Original against Tinea pedis
Phase IV

2004
Voltaren Emugel versus Vehiclegel against Thrombophlebitis superficialis,
Phase IV

2004
Pleuromutilin-cream/Vehicle-cream versus Cephalexin-Tab/Placebo-Tab against superinfected chronic Dermatoses,
Phase III

2005
Methylprednisolonaceponat-cream versus Tacrolimus-cream for eccemtherapy on childrens in 2. to 15. live-year
Phase IV

2005
Pleuromutilincream versus Fusidinacid-cream against Impetigo contagiosa,
Phase III

2005
Cyclodextringel versus Vehiclegel against Herpes genitalis
Phase II

2006
Pimercrolismuscream + Corticosteroidcream versus Vehicle-cream + Corticosteroidcream for therapy of severe atopic Dermatitis in childrens between 2-17 live-years
Phase IV

2006
systemic CC 1004 for therapy of moderate to severe Plaque-Psoriasis, dosisfinding, versus Placebo
Phase II

2006
topical application of Abafungincreame versus Canesten-cream and Vehicle-cream against Tinea pedis
Phase III

2006
intralesional Triamcinolonacetonid against scar-keloids: controlled comparison of parallel-groups,
Phase IV

2006
topical apllication of NOQ-Gel versus Vehicle-Gel for Prophylaxis and Therapy of Herpes labialis recidivans
Phase III

2007
Parallel-Group-Study to demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxid Topical Gel versus substances alone and vehicle (FDA)
Phase III

2007
Systemic Placebo and Cyclosporin controlled study with ISA247 in severe Plaque Psoriasis Patient
Phase III

2007
A new System for sucutaneous Application of a systemic Biologic independent by Patients with moderate to severe Psoriasis
Phase III

2008

Topical formulation of calcipotriol plus hydrocrotisone in psoriasis vulgaris on the face and on the intertriginous areas versus substances alone and versus verhicle, Phase III

2008

New system of non-surgical nail ablation for treatment of onychomycosis, placebo controlled, Phase III

2009

Multcentre, randomized, double blind within frequency of administration, placebo controlled, dose-finding, parallel-group, efficacy and safety study of 3 doses of P-3058 nail laquer given for 52 weeks in patients with onychomycosis, Phase III

2009

Efficacy and safety of clobetasol propionaet shampoo 0.05% used in association with an antifungal shampoo in the treatment of moderate to severe scalp seborrhoic dermatitis, Phase IV

2009

A Phase III study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with hydrocortisone 10 mg/g, ointment, both applied once daily in the treatment of psoriasis vulgaris on the face and intertriginous areas in paediatrics patients (aged 6 to 17 years), Phase III

2010

A phase II, proof of concept and dose finding study, investigating treatment efficacy of LEO 29102 cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g), LEO 29102 cream vehicle, and ELIDEL (pimecrolimus) cream 10 mg/g, after cutaneous administration in areas with atopic dermatitis twice daily four weeks, Phase II

2010

A double-blind, vehicle-controlled, parallel group study assessing the activity of CD5024 1% cream in subjects with papulopustular rosacea over 12 weeks treatment, Phase II

2011

A Phase 3, multi-site, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of 2 oral doses of CP-690,550 and 1 subcutaneous dose of etanercept in subjects with moderate to severe chronic plaque psoriasis, Phase III

2011

A Phase 3, multi-site, randomized, double-blind, placebo-controlled, paralle-group study of the efficacy and safety of 2 oral doses of CP-690,550 in subjects with moderate to severe chronic plaque psoriasis, Phase III, (EUDRACT-No 2010-020003-73)

2012

A Phase 3, multi-site, open label study of the longterm safety and tolerability of 2 oral doses of CP-690,550 in subjects with moderate to severe chronic plaque psoriasis, Phase III, (EUDRACT-No 2010-02003-15)

 

2012/2013

Placebo-controlled double-blind trial investiagting the efficacy and tolerability of posterisan akut with lidocain 60mg/suppository in abatement of compliants associated with hemorrhoids, Phase III, EUDRACT-No 2012-002083-15)

2013

A multi-center, randomized, double-blind, three-arm, 16 week, adaptive phase III clinical study to investigate the efficacy and safety of LAS41008 vs LASW1835 and vs placebo in patients with moderate to severe chronich plaque psoriasis, Phase III, (EUDRA-CT-No 2012-000055-13)

2013

An international prospective, double-blind, placebo-controlled phase III RCT in which patients with moderate to severe psoriasis vulgarus are treated with s.c. methotrexat using an optimized treatment schedule, Phase III, (EUDRACT-No 2012-002716-10)

2014

A phase IIa, 28-day treatment, multi-center, randomized, comparator-controlled, observer-blind trial with an intra-individual left/right comparison to investigate the anti-psoriatic efficacy and the safety of an LAS41004 formulation in comparison to an active reference in patients with mild to moderate plaque psoriasis, EUDRACT-No 2013-003757-22

2014

A phase II trial to evaluate the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis - parallel group comparison. EUDRACT-No. 2013-004519-28

2015

Open-label study to asses the tolerance and efficacy of the product RV4421A BS0042, applied in paediatric and adult populations with mild to moderate atopic dermatitis for three weeks MEDICAL PRODUCT RV4421A2013428

2016

A multicenter, randomized, double-blind, parallel, vehicl-controlled study to evaluate the efficacy and safety of P-3058 10% nail solution in the treatment of onychomycosis. EUDRACT-No. 2015-000561-31

2016

Doppelblinde, randomisierte klinische Studie zum Vergleich der Wirksamkeit und Verträgkichkeitvon Gentamicin 0.1%-Betamethason 0.05% Salbe (Test) vs. Diprogenta-Salbe (Referenz) vs. Grundlage bei Patienten mit bakteriell infiziertem Ekzemen. EUDRACT-No. 2014-005519-18

2016

A Phase 2a, proof of concept trial, testing twice daily application of LEO 124249 ointment 30mg/g in the treatment of mild to moderate inverse psoriasis. EUDRACT-No. 2015-002098-40

2017

Double-blind, randomized clinical study comparing efficacy and safety of Calcipotriol 50ug/g_Betamethasone 0.5mg/g Gel (Test) vs. Daivobet Gel (Reference) vs. Vehicle in patients with scapl psoriasis. EUDRACT-No.: 2016-001106-42

2017

Double-blind, randomised clinical study comparing efficacy and safety of Imiquimod 5% Cream (Test) vs. Aldara 5% Cream (Reference) vs. Vehicle in patients with actinic keratosis. EUDRACT-No.: 2016-000712-15