Visual Universitätsmedizin Mainz

Archiv

Indikation

Protokollnummer

Titel

Phase

Psoriasis vulgaris

Bili1311.4

BI 655066 versus placebo in a multicenter randomized double-blind study in patients with moderate to severe chronic plaque psoriasis evaluating the efficacy and safety with randomized withdrawl and re-treatment

III

Psoriasis vulgaris

IM011-011

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects with Moderate to Severe Psoriasis

II

Psoriasis vulgaris

CAIN457A2304E1

A multicenter, double-blind and open-label, 2 year extension study of subcutaneous secukinumab in prefilled syringes, assessing long-term safety, tolerability and efficacy in subjects with moderate to severe chronic plaque-type psoriasis treated with either a fixed dose regimen or on a retreatment at start of relapse regimen

III

Psoriasis vulgaris

PS0003

A phase 3, multicenter, randomized, double-blind, parallel-group, study followed by a dose-blind period and open-label follow-up to evaluate the efficacy and safety of certolizumab pegol in subjects with moderate to severe chronic plaque psoriasis

III

Psoriasis vulgaris

I1F-MC-RHAZ

A multicenter Study with a randomized, double-blind, placebo-controlled Induction dosing period followed by a randomized maintenance dosing Period and a long-term extension period to evaluate the efficacy and safety of LY2439821 in patients with moderate-to-severe palque psoriasis

III

Psoriasis vulgaris

CNTO1959PSO3008

Multicenter, randomized, open-label, efficacy assessor-blinded, active comparator-controlled phase 3b study to compare the efficacy of guselkumab to fumaric acid esters (Fumaderm® initial/ Fumaderm®) for adult patients with moderate to severe plaque psoriasis who are candidates for and naive to systemic treatment (POLARIS)

IIIb

Psoriasis vulgaris

Cain457A3401

An open-label, prospective, non-randomized, multicenter study to evaluate clear skin effect on health-related quality of life outcomes at 16 and 52 weeks in patients with moderate to severe plaque psoriasis treated with secukinumab 300mg s.c. with or without previous exposure to systemic therapy

IV

Psoriasis vulgaris

I1F-MC-RHBC

A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis with a Long-Term Extension Period

III

Psoriasis vulgaris bei Kindern

CC-10004 PPSO-001

A Phase 2, multicenter, open-label, study to assess the safety, tolerability and pharmakokinetics of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis

II

Psoriasis vulgaris bei Kindern

CAIN457A2310

A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single-blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis

III

Chronisch spontane Urtikaria

QGE031C2201

A multicenter, randomized, double-blind, placebo and active-controlled phase 2b dose-finding study of QGE031 as add-on therapy to investigate the efficacy and safety in patients with hronic spontaneous urticaria (CSU)

IIb

Chronisch spontane Urtikaria

CQGE031C2201E1

An open label, multicenter, extention study to evaluate the Long-term safety of QGE031 240mg s.c. given every 4 weeks for 53 weeks in Cronic Spontaneous Urticaria patients who completed study CQGE031C2201

IIb

Hereditäre Angioödeme

Dyax DX-2930-03

A multicenter, randomized, double-blind, placebo-controlled efficacy and safety study to evaluate DX-2930 for laong-term prophylaxis against acute attacks of hereditary angioedema (HAE)

III

Hereditäre Angioödeme

Dyax DX-2930-04

HELP Study Extension: An open-label study to evaluate the long-term safety and efficacy of DX-2930 for prevention against acute attacks of hereditary angioedema (HAE)

III

Atopische Dermatitis

R668-AD-1225

A phase 3 confirmatory study investigating the efficacy and safty of Dupilumab monotherapy administered to adult patients with moderate to severe atopic Dermatitis

III

Onychomykose

PM1331

A multicenter, randomized, double-blind, parallel, vehicle-controlles study to evaluate the efficacy and safety of P-3058 10% nail solution in the treatment of Onychomycosis

III

Pemphigus vulgaris

Pemphix WA29330

A randomized, double-blind, double-dummy, active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris

III

Akne vulgaris

RD.06.SPR.18251

A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50μg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris

III

Archiv (älter)

Indikation

Protokollnummer

Titel

Phase

Psoriasis

C0168T38

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction and Maintenance Therapy in Patients with Moderate to Severe Plaque Psoriasis

III

Psoriasis

0881A6-101764

A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects with Psoriasis

IIIb/IV

Psoriasis

P04320

Study to determine the non inferiory of GROUP I("high need") compared to GROUP II (low need") concerning the efficacy of infliximab with respect to safety and tolerability in patients suffering from chronic plaque psoriasis (psoriasis vulgaris)

IIIb

Psoriasis

CDP870/ RPCE05C0901

Multicenter, dose response, randomized, double-blind, 3 arms, placebo controlled clinical trial to evaluate the efficacy and the safety of subcutaneous CDP870 (certozumab pegol) at 2 different 12 weeks dose regimens (400mg initial dose at week 0 with 200 mg every 2 weeks thereafter and 400 mg every 2 weeks), followed by a minimum of 12 weeks of follow-up without treatment (or until relapse) in subjects suffering from moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy and/or phototherapy and/or photochemotherapy.

II

Psoriasis

VB-201-006-A

A randomized, double-blind, 12-week, dose ranging, placebo-controlled study to evaluate (1) the efficacy and safety of oral VB-201 on Carotid Artery and ascending Aorta PET 18FDG Uptake in psoriasis patients with abnormal baseline pet18fdg scans

II

Psoriasis

C0743T09

A Phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluation the efficacy and safety of CNTO 1275 in the treatmen of subject with moderate Plaque-type psoriasis

III

Psoriasis

n.a.

A 12-week, double-blind, randomised, placebo-controlled, modified close-escalation trial to investigate safety, efficacy, and pharmacokinetics of BIRT 2584 XX tablets of doses of 100,300 and 500 mg administered once daily in patients with moderate to severe psoriasis with a 12 week treatment extension for PASI 50 responders;

IIa/b

Psoriasis

C8044/ RPCE05L1402

Follow-up study C87040: Multicenter, single blind study to describe the efficacy and safety of re-treatment with CDP870 (certolizumab pegol) subcunateous at 2 different dose regimens (400 mg intial dose at week 0 with 200 mg every 2 weeks thereafter and 400 mg every 2 weeks) or placebo for 12 weeks, in subjects suffering from moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy and/or phototherapy and/or Photochemotherapym having responded to treatment in study C87040 and having subsequently relapsed

II

Psoriasis

ISA05-25

A Phase III, Randomized, Multicenter, Double-Blind, Placebo and Ciclosporine Controlled Study of ISA247 in Plaque Psoriasis Patients (ISA 05/25)

III

Psoriasis

C0743T12

Eine multizentrische, randomisierte Studie zum Vergleich von CNTO 1275 und Etanercept in der Behandlung von mittelschwerer bis schwerer Psoriasis vulgaris, Phase III;

III

Psoriasis

0881A6-3326

A 3 month, randomised, open label, parallel group descriptive study to explore and compare perceptions and satisfaction for two different delivery machanisms for etanercept (Etanercept auto injector and the etanerecept prefilled syringe) in patients with rheumatoid arthritis;

III

Psoriasis

M10-060

A Multi-center, Randomized, Vehicle-controlled Study to Assess the Efficacy and Safety of Adamilumab in Combination with Topical Treamtent (Calcipotriol/Bethamethasone) in Subjects with Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE), Site 1719

IIIb

Psoriasis

AC-058A200

Multicenter, randomized, double-blind, placebo-controlled, Phase Iia study to evaluate the efficacy, safety, and tolerability of ACT-128800, an S1P1 receptor agonist, administered for 6 weeks to subjects with moderate to severe chronic plaque psoriasis;

IIa

Psoriasis

M41008-1102

A multi-center, randomized, double-blinded, three-arm, 16 week, adaptive phase III clinical study to investigate the effiacy and safety of LAS41008 vs LASW1835 and vs placebo in patients with moderate to severe chronic plaque psoriasis

III

Psoriasis

066-007/08

Eine multizentrische, randomisierte, doppel-blinde, placebo-kontrollierte intraindividuell-vergleichende Phase Iia-Studie zur Wirksamkeit und Sicherheit der Anwendung von 2 % AVT-02UE-Salbe an jedem zweiten Tag in der Behandlung von leichter bis mittelschwerer Psoriasis vulgaris;

IIa

Psoriasis

Gepard Long Life

Identifizierung von Psoriasis-Arthritis-Patienten in der Kohorte dermatologisch betreuter Psoriasis Patienten

n.a.

Psoriasis

VB-201-006-A

A randomized, double-blind, 12-week, dose ranging, placebo-controlled study to evaluate (1) the efficacy and safety of oral VB-201 on Carotid Artery and ascending Aorta PET 18FDG Uptake in psoriasis patients with abnormal baseline pet18fdg scans

II

Psoriasis

Gepard Long Life EXTENSION

Dokumentation und Auswertung gesundheitsbezogener Daten, die im Rahmen des epidemiologischen Studienprojectes "Gepard-Long Identifikation von Psoriasisarthritis-Patienten in einer Kohorte von Patienten mit Psoriasis erhoben werden."

n.a.

Psoriasis

DSC/03/2357/07

A randomized, double-blind, placebo-controlled,, multinational, multicentre, dose-finding parallel goup study to investigate safety and efficacy of ITF2357 in patients with moderate to severe plaque psoriasis

IIa

Psoriasis

C0168T45

A multicenter international observational study of long-term safety of infliximab (Remicade)

IV

Psoriasis

CAIN457ADE04

A randomized, double-blind, multicenter study to assess the efficacy and safety of 16 weeks secukinumab dosage interval shortening (2-weekly 300mg s.c.) in comparison to continued standard treatment (4-weekly 300mg s.c.) in patients with moderate-severe plaque type psoriasis who achieved less than clear or almost clear skin (PASI response ≥75 to PASI <90) after 16 weeks under the standard dose of secukinumab

III b

Psoriasis

M13-674

A phase3, Multicenter, double-blind, randomized, parallel-arm, placebo-controlled study to evaluate the safety and efficacy of Adalimumab for treatment of nail psoriasis in subjects with chronic plaque psoriasis

III

Psoriasis

CAIN457A2317

A 52-week, multicenter, randomized, double-blind study of subcutaneous secukinumab to demonstrate efficacy as assessed by Psoriasis Area and Severety Index at 6 weeks of treatment compared to ustekinumab and to assess long-term safety, tolerability and ef

IIIb

Psoriasis

CAIN457ADE02

A randomized, double-blind, placebo-controlled, multicenter, exploratory evaluation of surrogate markers of cardiovaskular risk in patients with active chronic plaque-type psoriasis treated for up to 52 weeks with subcutaneous (s.c.) sekukinumab (300mg or 150mg).

IIIb

Psoriasis

MT-1303-E06

A Phase IIa, Multicentre, Randomised, Double Blind, Parallel Group, Placebo-Controlled Study to Evaluate Safety, Tolerability and Clinical Effiacy of MT-1303 in Subjects with Moderate to Severe Chronic Plaque Psorias

IIa

Psoriasis

ABP501

A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis

III

Psoriasis

CAIN457A2304

CAIN457A2304_Sculpture: A randomized, double-blind, multicenter study of subcoutaneous secukinumanb, assessing Psoriasis Area and Severity INDEX (PASI) response and maintenance of plague-type psoriasis on either a fixed dose regimen or on a retreatment at start od relapse regimen

III

Psoriasis

CAIN457A2307

CAIN457A2307_STATURE: A randomized, double-blind, double dummy , multicenter study to assess the safety, tolerability and long-term efficacy of intra-venous (10 mg/kg) and subcutaneous (300mg) secukinumab in subjects with moderate to severe chronic plague-type psoriasis who are partial responders to secukinumab

III

Psoriasis

A3921061

A phase 3, multi-site,open-label study of the long term safety and tolerability of 2 oral doses of CP-690,550 in subjects with moderate to severe chronic plaque psoriasis

III

Psoriasis

A3921080

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 Entanercept in Subjects with Moderate to Severe Chronic Plague Psoriasis

III

Psoriasis

CAIN457A2211E1

A multicenter extension trial of subcutaneously adminstered AIN457 in patients with moderate to severe chronic plaque-type psoriasis

II

Psoriasis

P05495-806

A Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design, Dose-Range Finding Study of Subcutaneous SCH 900222 in Subjects with Moderate-to-Severe Chronic Plaque Posriasis

II

Psoriasis

LEO 80190-O21

Calcipotriol plus hydrocortisone in psoriasis vulgaris on the face and on the intertriginous areas;

III

Psoriasis

n.a.

A randomised placebo-controlled double-blind dose escalation study to evaluate the efficacy, safety and pharmacokinetic properties of the humanised CD4 monoclonal antibody BT061 in patients with chronic plaque psoriasis

I/Iia

Psoriasis

CAIN457A2211

A randomized, double-blind, placebo controlled, multicenter regimen finding study of subcutaneously administered AIN 457, assessing Psoriasis Area and Severity Index (PASI) response in patients with moderate to severe chronic plaque-type psoriasis.

II

Psoriasis

1311.2

A 48 weeks study of three different dose regimes of BI 655066 administered subcutanoeusly in patients with moderate to severe chronic plaque psoriasis (randomised, dose-ranging, active-comperator-controlled (ustekinumab), double blindwithin dose groups of BI 655066

II

Psoriasis Kind

CNTO1275PSO3006

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis

III

Psoriasis Kind

B1801035

A long-term, prospective, observational cohort study of the safety and effectiveness of etanercept in the treatment of paediatric psoriasis patients in a naturalistic setting: a post-authorisation safety study

n.a.

Psoriasis Kind

027-008

A 2:1 randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Fumaderm in young patients aged 10 to 17 years with moderate to severe psoriasis vulgaris (KIFUderm study)

IIIb

Psoriasis Kind

M04-717

M04-717: A Multicentre, Randomises, Double-Dummy-Blind Study Evaluiating Two Doses of Adalimumab versus Methotrexate (MTX) in Paediatric Subjects with Chronic Plague Psoriasis (Ps) Icorporating Administrative Changes 1 and 2 and Amendments 1 and 2

III

Psoriasis Arthritis

CNTO1275PSA3001

PSUMMIT I- A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-LL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis

III

Psoriasis inversa

LP0133-1182

A phase 2a, proof of concept trial, testing twice daily application of LEO 124249 ointment 30 mg/g in treatment of mild to moderate inverse psoriasis

II a

Pruritus/atopische Dermatitis

M546102-EU 03

M546102-EU 03; A randomized, placebo-controlled-double-blind, parallel-group, multi-center Phase II b dose-finding study of M516102 in the treatment of pruritus associated with atopic dermatitis;

IIb

Atopische Dermatitis

R846-AD-1105

Random., doppelblinde ,placebokontrollierte Studie mit sequentiell ansteigender Dosierung zu klinischen Aktivitätsprüfung , Sicherheit, Verträglichkeit und Pharmakokinetik. Einer einzelnen i.v.Dosis von REG N846 bei refraktären moderaten bis schwerwiegenden Pruritus bei erwachsenen Patienten mit moderater bis schwerer Atopischen Dermatitis

Ib

Atopische Dermatitis

101-PG-PSC-150

A randomized, double blinded, placebo controlled multicenter study for the efficacy and safety of an Add-on-Therapy of Depigoid House dust mites (HDM) in patients suffering from moderate to severe atopic eczema

III

Atopische Dermatitis

266-03/06

A multicenter, randomized, double-blind placebo-controlled, intra-individual-comparison phase Iia trial to evaluate the efficacy and safety of 2% AVT-02 UE ointment in the topical treatment of mild to moderate atopic dermatitis

IIa

atopische Dermatitis

R668-AD-1334

A Phase 3 confirmatory study investigating the efficacy and safety of dupilumab monotherpy administered to adult patients with moderate-to-severe atopic dermatitis

III

Atopische Dermatitis

R668-AD-1415

A Phase 3, randomized, double-blind, placebo-controlled study Investigating the efficacy and safety of multiple dupilumab dose regimens administered as monotherapy for maintaining treatment response in patients with atopic dermatitis

III

Atopische Dermatitis

ZPL389/101

A randomized, double-blind, placebo controlled, parallel group study to determine the effects of 8 weeks treatment with oral ZPL-3893787 (30mg od X 56 days) on pruritus in adult subjects with moderate to severe atopic dermatitis

II

Atopische Dermatitis

GS29250

A phase II, randomized,double-blind,placebo-controlled study to evaluate the safety and efficacy of lebrikizumab in patients with persistent moderate to severe atopic dermatitis that is inadequately controlled by topical corticosteroids

II

Atopische Dermatitis

CIM003JG

A Phase II, Randomized,double-blind,placebo-controlled,multiple-dose study to evaluate the safety, tolerability, and efficacy of CIM331 in Atopic Dermatitis patients who are inadequately controlled by or intolerant to topical therapy

II

Atopische Dermatitis

R668-AD-1424

A PHASE 3 STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF DUPILUMAB ADMINISTERED TO ADULT PATIENTS WITH SEVERE ATOPIC DERMATITIS WHO ARE NOT ADEQUATELY CONTROLLED WITH OR ARE INTOLERANT TO ORAL CYCLOSPORINE A, OR WHEN THIS TREATMENT IS NOT MEDICALLY ADVISABLE

III

Chronischer Pruritus

UKM10_0037

Aprepitant in histamine -refractory chronic pruritus: a multicenter, randomized, double-blnd, placebo-controlled, cross-over, phase II trial

II

pruritische Dermatosen

A-05610-2940

Wirksamkeit und Verträglichkeit von Azelastin.HC1 (4.4mg, od), Cetirizin (10mg, od) und Placebo bei Patienten mit allergischen und urtikariellen pruritischen Dermatosen

III

Prurigo

TCP 102

A randomized, double-blind, placebo-controlled, study of the Neurokinin-1 receptor antogonist VDP-737 in subjects with prurigo nodularis

II

Handekzem

LP0133-1180

A Phase 2a, Proof of Concept Trail, testing twice daily applications of LEO 124249 ointment 30mg/g in the treatment of chronic hand eczena

IIa

Mamillenekzem

n.a.

Bepanthen bei stillenden Müttern mit Mamillenekzem; Prüfung der Wirksamkeit, Verträglichkeit und Handhabung von Bepanthen Salbe zur Behandlung der Mamillitis bei stillenden Müttern;

AWB

Rhinokonjunktivitis

AL0704rP

A multicentre, multinational, randomised placebo-controlled double-blind pivotal clinical trial for evaluation of safety and efficacy of specific immunotherapy with a cocktail of recombinant major allergenes of Timothy Grass Pollen (Phleum pratense) adsorbed onto alluminium - hydroxide in patients with IgE-mediated allergic rhinoconjunctivits with/without controlles asthma (AMETHYST)

III

Rhinokonjunktivitis

AB0602

A randomised, double-blind, placebo-controlled, multi-centre, multi-national Phase II/III follow-up study to assesslong-term efficacy and safety of three different does regimes of oralgen Grass pollen in patients with grass pollen-related allergic rhinoconjunktivitis

II/III

Allergische Rhinitis/ Rhinoconjuctivitis

AL0906rP

Open label phase ll multicenter clinical trial to evaluate safety during shortened uptitration of an allergoid gradd pollen preparation in adult patients with IgE mediated allergic rhinithis/ rhinoconjunctivitis with or without controlled broncial asthma

II

Birkenpollen Allergie

Basalit

Multizentrische, randomisierte, Plazebo-kontrollierte, 2-armige Doppelblindstudie zum Nachweis der Wrksamkeit und Verträglichkeit einer spezifischen Immuntherapie mit einer Aluminiumhydroxid-absorbierten hypoallergenen rekombinanten variante der Hauptallergens der Birkenpollen, rBET v1-FV, auf die Birkenpollen assozierte Soja-Allergie BASALIT (Birch Associated Soy Allergy and Immuno-Therapy)

IIb

Allergische Rhinitis/ Rhinoconjuctivitis

603-PG-PSC-191

Depigoid Birch Multicenter, placebo-controlled,long-term study of Depigoid Birch 5000vin adults an adolescents with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma

III

Rhinokonjunktivitis

6043-PG-PSC-192

A randomized, double-blind, parallel group, multicentre study to assess the efficacy and safety of four concentrations of Depigoid Phleum in patients with allergic rhinitis and/or Rhinoconjunctivitis with or without intermittent asthma

II

Rhinitis Rhinoconjunctivitis

603-PG-PSC-74

A randomised, double blinded, placebo controlled multicenter study for the efficacy and safety of Depigoid birch pollen

III

Rhinitis Rhinoconjunctivitis

Depigoid Phleum Pro 2013

Non-interventional Study in Allergic Patients suffering from Grass Pollen induced rhinitis/Rhinoconjunctivits with or without Asthma. Retrospective assessment of the Efficacy of a perennial specific immunotherapy on the allergy symptomps/ Disease activity during the Pollen Season

n.a.

Rhinokonjunktivitis

V034.04

Randomised, double-blind, placebo-controlled, multinational, multi-cenre, Phase IIb/III study of the efficacy and safety of three doses of sublingual immunotherapy (SLIT) administered as tablets once daily to patients suffering from grasspollen rhinoconjunctivits

IIb/III

Urtikaria Neurodermitis

Bearbeitungsnummer - Ethik:837.340.0715875

Einfluss des Nahrungsergänzungsmittels Blagovitol auf die Lebensqualität von Patienten mit Chronischer Urtikaria und Neurodermitis

n.a.

Chronische Urtikaria

n.a.

Chronic Urticaria-Long Term Assessment of Effects of Rupatadine. A multi-center, randomized, double blind, dose escalating phase III study on the efficacy, safety and long term outcome of continuous vs. on demand treatment of chronic spontaneous urticaria with rupatadine.

III

Chronische Urtikaria

RPCE98A1901

Open, Phase III Multicentre Trial, assessing the safety and efficacy of 15mg Efletrizine Capsules administered orally twice a day, for up to one year, to adult patients with chronic urticaria

III

Chronische Urtikaria

n.a.

Behandl. der chron.Urtikaria mit Histaglobin

n.a.

Chronische Urtikaria

n.a.

Behandlung der chronischen Urtikaria mit autologem Vollblut- Eigenblutbehandlung der Urtikaria

n.a.

Chronische Urtikaria

IGE025E5003

ASSURE-CSU: Assessment of the Economic and Humanistic Burden of Chronic Spontaneous/idiopathic Urticaria Patients

n.a.

Chronische Urtikaria

DC1-CT-001/01

A phase II, multicentre, randomised, double-blind, placebo controlled, parallel group study to investigate the efficacy of 100, 200 and 300 mg t.i.d. Fluormethylhistidine (FMH) in patients with chronic urtikaria;

II

Chronische Urtikaria

Histaminintoleranz

prospektive Beobachtungsstudie: histaminintoleranz bei chronisch spontaner Urtikaria

 

Chronische Urtikaria

001/2002

Symbioflor bei chron. Urtikaria, Symbiopharm; Behandlung der chronischen Urtikaria mit Mikrobiologika

n.a.

Chronische Urtikaria

GX29107

Eine Multizentische, Randomisierte, Doppelblinde, Placebo-Kontrollierte Pilotstudie mit Quilizumab bei Patienten mit refraktärer chronisch-spontaner Urtikaria

II

Urtikaria

 

A two center double blind placebo controlled study in parallel desing to asses the efficacy and safety of 150 and 300 mg omalizumab in subjects with antihisatmineresitant cold contact urticaria (CCU)

II

Chronische Urtikaria

CIGE025E2201

CIGE: Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Phase-II-Studie zur Bestimmung der Wirkungsweise von Omalizumab bei Patienten mit chronischer idiopathischer Urtikaria (CIU), die unter Behandlung mit Antihistaminika (H1) symptomatisch bleiben

II

Urtikaria

CIGE025EDE16

X-ACT: A randomized, double-blind, placebo-controlled, multicenter, 28-week treatment study with an 8 week follow-up period to investigate the impact of subcutaneous Omalizumab on quality of life measures as well as the

IIIb

Chronische Urtikaria

Q4883g

Glacial: A Phase III, Multicentre, Randomized, Double-Blind, Placebo Controlled Safety Study of Xoliar (Omalizumab) in Patients with Chronix Idiopathic Urticaria (CIU) who remain symptomatic despite Treatment with H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

III

Chronische Urtikaria

Q4882g

A Phase III, Multicenter, Randomized, Double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy, response duration and safety of Xolaire (Omalizumab) in patients with chronic idiopathic urticarial (CIU) who remain symptomatic despite antihistamine treatment (H1) (ASTERIA II)

III

Chronische Urtikaria

CIGE025ADE05

X-Cuisite # CIGE025ADE05-Novartis; A randomised, 24 week, double-blind, placebo-controlled, parallel-group, multicentre study to assess the efficacy and safety of Omalizumab in adult patients with chronic urticaria who exhibit IgE against thyreoperoxidase;

II

Chronische Urtikaria

A00394/ RPCEA0501

A multicentre, double-blind, two parallel groups, randomized trial over four weeks of treatment to compare the clinical efficacyand safety of Levocetirizine 5 mg oral capsules once daily in the morning vs. Desloratadine 5 mg oral capsules once daily in the morning in patients suffering from chronic Idiopathic Urticaria(CIU)

IV

Chronische Urtikaria

MIARCU 01/2008

Wirksamkeit und Verträglichkeit von Miltefosin bei der Behandlung der Antihistaminika-resistenten chronischen Urtikaria;

II

Chronische Urtikaria

Q4577g

A Phase II, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study of Xolair in patients with chronic idiopathic urticaria (CIU) who remain symptomatic with antihistamine treatment H1);

II

Urtikaria

AECUDATT

Multicenter, double-blind, dose escalating study to compare the effects of 5 mg, 10 mg and 20 mg of Desloratadine in patients with acquiered co-ed urtikaria (ACU)

II

Chronische Urtikaria

P04849

A study of the efficacy, safety and quality of life (QOL) in patients with chronic idiopathic urticaria dosed with AERIUS Tablets ( 5mg, 10 mg or 20 mg once daily)

IV

Angioödem

HCR: 565/DY

Open label single ascending intravenous dose study to assess the tolerability and efficacy of DX-88 administered following onset of peripheral and /or facialedema of abdominal symptoms in patients with angioedema

n.a.

HAE

CSL930_3002

An open-label, randomized study to evaluate the long-term clinical safety and efficacy of subcutaneous administration of human plasma-derived C1-esterase inhibitor in the prophylactic treatment of hereditary angioedema

IIIb

HAE

HGT-FIR-086

A Multicenter, open-label, non-randomized study to assess the pharmacokinetics, tolerability, and safety of a single subcutaneous administration of icatibant in children and asolescents with hereditary angioedema

III

HAE

0624-206

A Phase 2, Randomized, Double Blind, Multicenter, Dose Ranging Crossover Study to Evaluate the Safety and Effiacy of Subcutaneous Administration of CINRYZE (C1 Esterase Inhibitor(Human)) with Recombinant Human Hyaluronidase (rHuPH20) for the Prevention of Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema

II

HAE

BCX4161-203

A Phase 2A Double-Blind, Placebo-Controlled 2-Period Crossover Study to evaluate the safety and efficacy of BCX4161 As a prophylactic treatment to reduce the frequency of attacks in subjects with hereditary angioedema

IIa

HAE

CSL830_2001

Eine offene Cross-over Dosisfindungssudie zur Evaluierung von Pharmakokinetik. Pharmakodynamik und Sicherheit der subkutanen Verabreichung eines aus menschlichem Plasma gewonnenen C1-Esterase-Inhibitors bei Patienten mit hereditärem Angioödem

n.a.

HAE

JE049-3101

Open-label, Multicenter Study to Evaluate Safety, Local Tolerability., Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema - EASSI

IIIb

HAE

JE 049#2102

Randomized, Double Blind, Controlled, Parallel-Group, Multicenter Study of a Subcutaneous Formulation of Icatibant vs Oral Tranexamic Acid for the Treamentof Hereditary Angioedema (HAE)

n.a.

Mastozytose

PA101-SM-02

Randomized, Double-blind, Placebo-controlled, Crossover Design, Efficacy and Safety Study with PA101 in Patients with Indolent Systemic Mastocytosis

Iia

Mastozytose

AB06006

Eine 24-wöchige, verlängerbare, prospektive, multizentrische, randomisierte, doppelblinde, plazebokontrollierte Phase III Studie mit zwei 1:1 randomisierten Parallelgruppen zum Vergleich der Wirksamkeit und Sicherheit von Masitinib bei 6mg/kg/Tag mit Plazebo bei der Behandlung von Patienten mit schwelender systemischer, indolenter systemischer oder kutaner Mastozytose, die zu Beeinträchtigungen führt.

III

Mastozytose

MICUMA

Efficacy and Safety of Miltefosine in Cutaneous Mastocytosis

II

Influenza Vaccine

810601

An open label Phase III study of a vero cell-derived whole virus H5N1 influenza vaccine to assess the immunogenicity and safety and to investigate the need for and timing of a booster vaccination;

III

Influenza Vaccine

n.a.

Single-blind randomized controlled Phase II/III study to investigate the immunogenicity and safety after a single vaccination with one of three different lots of an inactivated influenza vaccine (whole virion, vero-cell derived) in comparison to a licensed egg derived influenza vaccine for season 2004/2005

II/III

Hautinfektionen

DAP002

Daptomycin # DAP002, Site 09; A multicentre, randomised, assessor-blind study to evaluate eficcaca and safety of Daptomycin versus Vancomycin or Teicoplanin for treatment of complicated skin and soft tissue infection (cSSTI)

III

Hautinfektionen

BAY12-8039 / 11974

A prospective, randomized, double blind, multinational, multicenter trial comparing the safety and efficacy of sequential (intravenous/oral) moxifloxacin 400mg QD to intravenous piperacillin/tazobactam 4.0/5.0g IV every 8 hours followed by oral amoxicillin/clavularic acid tablets 875/125mg very 12 hours for the treatment of patients with complicated skin and skin structure infections

IIIb

Hautinfektionen

TMC-ORI-10-02

A multicenter, double-blinded, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin versus IV Vancomycin für the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infection (SOLOII)

III

Hautinfektionen

P903-07

A phase 3, Multicenter, Randomized,Double-blind,Comparative Study to Evaluate the Safety and Efficacy of Ceftalroline Versus Vancomycin plus Aztreonam in Adult Subjects with complicated skin and skin structure infection

III

Hautinfektionen

RO4908463/ WI18274

A phase II prospective, open label, randomized, active-controlled, parallel group, multi-center 'proof of concept' trial in adult patients with complicated skin structure infections requiring hospitalization

II

Acne Vulgaris

TT-AVUGANE-Acne-02

A double-blind, randomised, parallel group, placebo-controlled dose finding Phase II study to compare the efficacy and safety of topically apllied Avugane of different concentrations in subjects with mild to moderate acne vulgaris

IIb

Acne Vulgaris

DS207E-03

Randomisierte, doppelblinde, placebokontrolollierte Phase II-Studie zur Bestimmung der Wirksamkeit und der Sicherheit von DGLA-Creme zur topischen Anwendung bei Patienten mit leichter bis mittleschwerer Acne vulgaris

II

Hidradenitis Suppurativa

M11-313

A phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Hidradenitis Suppurativa

III

Hidradenitis Suppurativa

M12-555

A phase 3 open-label study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Hidradenitis Suppurativa

III

Rosacea

RD.03.SPR.40173

Efficacy and safety of CD5024 1 % cream versus metronidazole 0,75 % cream in subjects with papulopustular rosacea over 16 weeks treatment, followed by a 36 week extension period

III

Rosazea

FX2015-10

A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of two Different Doses of a Topical Minocycline Foam Compared to Vehicle in the Treatment of Papulopustular Rosacea

II

Impetigo, Kind

P-110881-01

A phase lll 2 arms, multicenter, randomised, double-blind study to asses the efficacy and safety of ozenoxacin 1% cream applied twice daily for 5 days versus placebo in the treatment of patients with impetigo

III

entzündliche Hauterkrankungen

n.a.

Identifizierung und Validierung von neuen Zielmolekülen für die Therapie von entzündlichen Hauterkrankungen

n.a.

Bilateral Primary Axillary Hyperhidrosis

191622-506

A Multicenter, Open Label Study of the Safety of BOTOX (Botulinum Toxin, Type A) Purified Neurotoxin Complex for the Treatment of Bilateral Primary Axillary Hyperhidrosis

III

Autoimmun Erkrankungen

CERL080ADE08

Measurement and Analysis of Patient reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Patients with Autoimmune Diseases treated with Mycophenolate (MPA)

III

Bullöses Pemphigoid

The Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Study

Blister - IIT: The Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Study, A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid

IV

Pemphigus vulgaris

WX17796

CELLCEPT (Mycophenolate Mofetil) in Pemphigus vulgaris

III

Bullöse Autoimmundermatosen

Popgen

Untersuchung der genetischen Suszeptibilität zur Ausbildung bullöser Autoimmundermatosen

IV

Systemische Sklerodermie

AC-055C303

Long-term, single-arm, open-label extension study of protocols AC-055C301 and AC -055C302 to assess the safety, tolerability and efficacy of macitentan in subjects with ischemic digital ulcers associated with systemic sclerosis

III

Pemphigus vulgaris

DRKS 00000566

IA PEM: Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-pem-study)

 

Onychomykose

CSFO327N2302

A randomized, double-blind,vehicle-controlled,multicenter, parallel-group study to assess the efficacy, safety and tolerability of topical terbinafine hydrogen chloride (HCI)formulation for 24 or 48 weeks of treatment in patients with mild to moderate toenails onychomycosis

III

Onychomykose

CSFO327N2303

A randomized, open-label, active-controlled, multicenter, parallel group study to assess the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride (HCI) formulation versus 5 % amorolfine nail lacqueur for 48 weeks of treatment in patients with mild to moderate toenail onchomykosis;

III

Onychomykose

RD.03.SPR40026

A multicentre, randomized, parallel groups, vehicle and active controlled study of Amorolfine 4 % and 10 % nail lacqueur new formulation in the topical treatment of distal and lateral subungual toenail onchomycosis;

II

Onychomykose

CSFO327L2302

A multicenter, randomized, double-blind, double-dummy, parallel-group study to assess the efficacy, safety and tolerability of new oral formulation terbinafine in patients witch onychomycosis of the toenails

III

Aktinische Keratose

X-03016-3271

Long-term effects of Aldara 5% cream and Solaraze 3% gel in the treatment of actinic keratoses on the face or scalp (LEIDA)

IV

Aktinische Keratose

X-03016-3284

Long-term effects of Aldara 5% cream and Solaraze 3% gel in the treatment of actinic keratoses on the face or scalp with respect to the risk of progression to in-situ and invasive squamous cell carcinoma (LEIDA 2)

IV

Chronisch venöse Insuffizienz

n.a.

A 12-week, double blind, randomised, placebo-controlled, multicentre trial to evalute efficacy and tolerability of Antistax film-coated tablets, 720 mg/day orally, in male and female patients suffering from chronic venous insufficiency

III

Chronisch venöse Insuffizienz

EDX09/01

Multicentre, double-blind, placebo-controlled,randomised clinical study to assess the efficacy and safety of Doxium 500 three times daily in patients suffering from chronic venous inusfficiency (CVI) CEAP Class C3 or C4

IV

Chronisch venöse Insuffizienz

1138.10 (HCR:984/BIG)

A 12-week, double-blind, randomised, placebo-controlled, multicentre trial to evaluate efficacy and tolerability of AntistaseR film-coated tablets 360 mg/day orally, in male and female patients suffering from chronic venous insuffiancy

III

chronisch venöse Insuffizienz

DX 2000/01 SSS

Multicentre, double-blind, placebo controlled, randomised clinical study to assess the efficacy and safety of Doxium 500 three times daily in patients suffering from chronic venous insufficiency (CVI) CEAP Class 3,4 or 5

IV

chronisch venöse Insuffizienz

CL3-05682-097-DEU

Efficacy of Daflon 500mg (2 tablets daily – 1000mg of micronized purified flavonoid fraction) in the treatment of patients suffering from vesperal edema related to chronic venous insufficency. International, multicenter, double-blind, randomized, placebo-controlled study

III

chronisch venöse Insuffizienz

1138.4 (HCR:827/BIG)

Eine 12-wöchige, doppelblinde, randomisierte, plazebokontrollierte, multizentrische Studie zur Untersuchung der Wirksamkeit und Verträglichkeit von Antistax Filmtabletten, 360mg/Tag oral, an männlichen und weiblichen Patienten mit chronisch venöser Insuffizienz

III

chronisch venöse Insuffizienz

9401-00C

Feasibility Clinical Protocol for the Percutaneous Venous Valve Bioprosthesis (PVVB)

n.a.

chronisch venöse Insuffizienz

9301-99C

Feasibility Clinical Protocol for the Monocusp Venous Valve Bioprosthesis (MVVB)

n.a.

chronisch venöse Insuffizienz

GSOB 301

An open label randomised stratifies, between subject, multicenter study to compare the safety and efficacy of Apligraf and a Duoderm R dressings in the treatment of chronic venous insufficiency leg ulcers

III

Ulcus Cruris vensosum

Collagenase OI DEB IMCR-D 2 P 3

Double-blind, placebo-controlled, comparative trial to evaluate the wound cleansing effect of Novuxol in patients with venous ulcus cruris

III

Wundheilung

BSH-12

Offene, verblindet ausgewertete, prospective, kontrollierte, randomisierte multizentirsche klinische Studie Phase lll zum intraindividuellen Vergleich der Wirksamkeit und Verträglichkeit von Oleogel-S10 im Vergleich zur Standardtherapie hinsichtlich der Beschleunigung der Wundheilung an Spalthautentnahmestellen mit Oleogel-S10.

III

Malignes Melanom

AJCC 2002

Phase III Protokoll zur Therapieoptimierung der adjuvanten Behandlung des malignen Melanoms im Stadium III (AJCC 2002): Intermittierende hochdosierte i.v.-Gabe von Interferon- alpha – 2b vs. Standard hochdosierte Interferon – alpha – 2b – Therapie.

III

Malignes Melanom

n.a.

Adjuvante Therapie im Stadium II beim malignen Melanom mit Interferon-alpha 2a: Intermittierende, intermediäre s.c.-Gabe versus Kontinuierliche intermediäre s.c.-Gabe

n.a.

Malignes Melanom

CA186006

A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects with Previously Treated Unresectable Stage III or Stage iV Melanoma;

II

node-positive melanoma

198-135

A randomized Phase II / III Trial of SCH 54031 PEG12000 Inerferon alfa-2b (PEG Intron) vs. INTRON A as Adjuvant Therapy for Melanoma

II /III

HSV Typ 1 Infektion

101-001

A randomized, placebo-controlles, active comparator, observer-blinded multicentre phase II trial to evaluate the efficacy and safety of D2D001 in the treatment of HSV type 1 infection in the region of the mouth and the opneings of the nose

II

Genitalherpes

HS2B3010

A randomised double-blind study to compare Valaciclor 500 mg twice daily given for three days with the standard five days course as episodic treatment for recurrent genital herpes

n.a.

Genitalwarzen

1426-IMIQ

An Open-Label, Multicenter, Safety and Efficacy Trial of Topical Imiquimod 5% Cream in the Treatment of External Anogenital Warts to Demonstrate Sustained Clearnace of Warts in Comparison with Ablative Methods

IIIb

erektile Dysfunktion

SDN-D-98-002

Studie zur Beurteilung der Zufriedenheit mit dem Behandlungsergebnis nach Therapie mit Viagra

n.a.

Borreliose

A2301 PXL202666

Borreliose: A Phase 3 randomized, double-blind, placebo-controlled study of SHB004 (10% topical azithromycin) administered locally twice daily for three consecutive days for the prevention of Borreliosos in subjects bitten by a tick

III

normale und empfindliche Haut

LaMer2013

Verträglichkeit und Anwendbarkeit von Inhaltsstoffen der Lamer Cosmetics AG Produkten insbesondere Einfluss von Meeresschlick, Meeresschlickextrakten und Meersalz auf die normale und empfindliche Haut. Monozentrische, verblindete, randomisierte Studie

n.a.

gesund

837.508.14

In-use test of sebamed Anti-Ageing Q10 Protection Cream and Firming Body Lotion for facial and body care

 

gesund

Flavo2010

Untersuchung der Beeinflussung der Phamakokinetik (Absorption und Bioverfügbarkeit) durch Flavonoide Quercetin und Naringin auf einen Cytochrom P450 3A4 präsiystemisch metabolisiertem Wirkstoff (Midazolam) und auf den präsystemischen Effluxtransport eines P-Glykoprotein-Substrats (Talinilol) in gesunden Probanden in einer kontrollierten, offenen, 3-fachen Cross-Over-Studie und einer kontrollierten, offenen, 4-fachen Cross-Over-Studie.

I

gesund

n.a.

Untersuchung des Einflusses einer verzögerten Freigabe aufdie Absorption und Bioverfügbarkeit intestinal metabolisierter Arzneistoffe anhand von einer Einmaldosis von Simvastatin 20 mg als Modellsubstanz bei gesunden Probanden ein einer offenen randomisierten 3-fach Cross-Over-Studie

I

gesund

1101_V19-PT2_01_Pilot_III

Safety and Efficacy Study of the V19 Laser Hair Removal Device in Adult Female Subjects

n.a.

gesund

Aciclovir 2011

Untersuchung der Beeinflussung der Pharmakokinetik (Absorption und Bioverfügbarkeit) eines parazellulär aufgenommenen Wirkstoffs (Aciclovir) durch Chitosan in gesunden, freiwilligen Probanden in einer kontrollierten, offenen, dreifachen Cross-Over-Studie

I

Hair Removal

1205_ Competitive Benchmarking Study

Evaluation and Comparison of Efficacy of Four Hair Removal Devices (V19 Laser, Venus Naked Skin IPL, Philips Lumea IPL and Remington iLight Pro IPL) in Adult Female Subjects

AWB

Hair Removal

CRIES - 2010

Placebokontrollierte, prospektive Beobachtung des Schmerzempfindens bei Probanden während der mechanischen Epilation mit dem Braun Expressive Epilationsgerät nach Auftragen von Lokaltherapeutika (Emla Creme, Polidocanol)

n.a.

Narben

MRZ90011_0028_3

A prospective, intra-individual randomized, observed blind, controlled Investigation to investigate the effectiveness and safety of overnight intensive patch (OIP) over 12 to 24 weeks in post dermatological surgery scars

n.a.

Ästhetik

Y-52-52120-214

A phase III, randomised, double.blind, placebo-controlled and open label phase, multicentre study to investigate the efficacy and safety of BTX-A-HAC NG in the treatment of moderate to severe glabellar lines, and assess the long term efficacy and safety of BTX-A-HAC NG following repeated treatments in this indication

III

Rejuvenation

0613_SC50000-01

Assessing Discomfort of Fractional Laser Skin Rejuvination Devices - Prototypes vs. Philips

AWB

n.a.

068-010

APQ_Adherence Studien-Nr.: 068-010

n.a.

n.a.

1108 V19-PT03 01

Safety and Efficacy Study of the V19 Laser Hair Removal Device in Adult Female Subjects

n.a.