Spots Global Cancer Trial Database for Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
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Trial Identification
Brief Title: Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
Official Title: A Phase 4 Trial Comparing the Cumulative Incidence of SCC After Treatment With Ingenol Mebutate and Imiquimod for Multiple Actinic Keratoses on Face and Scalp. A Multi-centre, Randomised, Two-arm, Open Label, Active-controlled, Parallel Group, 36-month Trial
Study ID: NCT01926496
Conditions
Study Description
Brief Summary: The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU Angers - Service de Dermatologie, Angers, , France
CHU Besançon - Hôpital Jean Minjoz, Besançon, , France
HOPITAL AVICENNE - Service de Dermatologie, Bobigny, , France
CHRU de Brest - Hôpital Morvan - Service de Dermatologie, Brest, , France
CHU Albert Michallon - Service de Dermatologie, Pôle Pluridisciplinaire de Médecine, Grenoble, , France
Hôpital Claude Huriez - CHRU de Lille - Clinique de Dermatologie, Lille, , France
Hôpital de la Timone - Service de Dermatologie Vénérologie, Marseille, , France
CHU de Nantes - Hôtel Dieu - Unité Fonctionnelle de Dermatologie Cancérologie, Nantes, , France
HOPITAL DE L ARCHET II - Service de Dermatologie-Vénérologie, Nice, , France
Hôpital Caremeau, Nimes, , France
HOPITAL COCHIN TARNIER - Service de Dermatologie, Paris, , France
Hôpital Saint Louis - Service de Dermatologie, Paris, , France
CHU BORDEAUX - Hôpital Haut-Lévêque, Pessac, , France
CHU Poitiers - Service de Dermatologie, Poitiers, , France
C.H.U. de Saint-Etienne - Hôpital Nord, Saint-Etienne, , France
Hôpital d'instruction des Armées Bégin - Clinique Dermatologique, St Mandé, , France
Hautarztpraxis Simon, Berlin, , Germany
Hauttumorzentrum Bochum Universitätsklinikum der Ruhr-Universität-Bochum, Bochum, , Germany
Praxis Streit Bucholz, Buchholz, , Germany
Dermatologisches Zentrum, Am Krankenhaus 1, Buxtehude, , Germany
Klinikum Dortmund - Hautklinik, Dortmund, , Germany
Mensingderma, Hamburg, , Germany
Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie, Leipzig, , Germany
Hautpraxis Dr. Ina Schulze, Markkleeberg, , Germany
Hauttumorzentrum Münster, Münster, , Germany
Klinik für Dermatologie und Allergologie, Klinikum Vest, Behandlungszentrum, Knappschaftskrankenhaus Recklinghausen,, Recklinghausen, , Germany
Universitätklinikum Regensburg, Regensburg, , Germany
Praxis Dr. Hoffmann, Witten, , Germany
Praxis Derma Hübinger, Wuppertal, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
Ninewells Hospital, Dundee, Angus, United Kingdom
Cumberland Infirmary, Carlisle, Cumbria, United Kingdom
Heavitree Hospital, Exeter, Devon, United Kingdom
Brighton General Hospital, Brighton, East Sussex, United Kingdom
Manchester Royal Infirmary, Manchester, Greater Manchester, United Kingdom
Monklands Hospital, Airdrie, Lanarkshire, United Kingdom
Scunthorpe General Hospital, Scunthorpe, Lincolnshire, United Kingdom
Royal Gwent Hospital, Newport, Monmouthshire, United Kingdom
Harrogate District Hospital, Harrogate, North Yorkshire, United Kingdom
Scarborough Hospital, Scarborough, North Yorkshire, United Kingdom
Cannock Chase Hospital, Cannock, Staffordshire, United Kingdom
East Surrey Hospital, Redhill, Surrey, United Kingdom
Southlands Hospital, Shoreham-by-Sea, West Sussex, United Kingdom
St Luke's Hospital, Bradford, West Yorkshire, United Kingdom
Chapel Allerton Hospital, Leeds, West Yorkshire, United Kingdom
Hull Royal Infirmary, Hull, , United Kingdom
Contact Details
Name: Rolf-Markus Szeimies, Prof.Dr.med.
Affiliation: Klinik für Dermatologie und Allergologie
Role: PRINCIPAL_INVESTIGATOR
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