Bei meiner laufenden Forschungs- tätigkeit geht es um die Umsetzung |  |
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