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Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Actinic Keratosis (AK)

Intervention: Ingenol Mebutate Gel, 0.015% (Drug); Imiquimod Cream, 5% (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Rolf- Markus Szeimies, Professor, Dr. med., Principal Investigator, Affiliation: Klinik für Dermatologie und Allergologie

Overall contact:
Maj Britt Larsen, ICTM, Phone: +4572262437, Ext: 2437, Email: maj.larsen@leo-pharma.com

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of SCC

Secondary outcome: Incidence of neoplasia

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Signed Informed Consent Form (ICF) prior to any trial-related procedures 2. Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp. 3. Subject at least 18 years of age 4. Female subjects must be of either: 1. Non-childbearing potential, or, 2. Childbearing potential, provided there is a confirmed negative urine pregnancy test 5. Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%) Exclusion Criteria: 1. Location of the selected treatment area:

- on the periorbital skin

- on the perioral skin/around the nostrils

- within 5 cm of an incompletely healed wound

- within 10 cm of a suspected BCC or SCC or other neoplasia

2. Selected treatment area lesions that have atypical clinical appearance (e. g., hypertrophic, hyperkeratotic or cutaneous horn). 3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area. 4. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area 5. Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1) 6. Organ transplant recipients 7. Immunosuppressed subjects (for example HIV patients) 8. Female subjects who are breastfeeding. 9. Subjects who are institutionalised by court order or by the local authority 10. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e. g. alcoholism, drug dependency or psychotic state)

Locations and Contacts

Maj Britt Larsen, ICTM, Phone: +4572262437, Ext: 2437, Email: maj.larsen@leo-pharma.com

CHU Angers - Service de Dermatologie, Angers 49933, France; Not yet recruiting
Yannick Le Corre, Dr.
Yannick Le Corre, Dr., Principal Investigator

CHU Besançon - Hôpital Jean Minjoz, Besançon 25030, France; Not yet recruiting
Francois Aubin, Prof.
Francois Aubin, Prof., Principal Investigator

HOPITAL AVICENNE - Service de Dermatologie, Bobigny 93009, France; Not yet recruiting
Fréderic Caux, Prof.
Fréderic Caux, Prof., Principal Investigator

CHRU de Brest - Hôpital Morvan - Service de Dermatologie, Brest 29609, France; Not yet recruiting
Laurent Misery, Prof.
Laurent Misery, Prof., Principal Investigator

CHU Albert Michallon - Service de Dermatologie, Pôle Pluridisciplinaire de Médecine, Grenoble 38043, France; Not yet recruiting
Marie-Thérése Leccia, Prof.
Marie-Thérèse Leccia, Prof., Principal Investigator

Hôpital Claude Huriez - CHRU de Lille - Clinique de Dermatologie, Lille 59037, France; Not yet recruiting
Laurent Mortier, Prof.
Laurent Mortier, Prof., Principal Investigator

Hôpital de la Timone - Service de Dermatologie Vénérologie, Marseille 13385, France; Not yet recruiting
Jean-Jacques Grob, Prof.
jean-Jacques Grob, Prof., Principal Investigator

CHU de Nantes - Hôtel Dieu - Unité Fonctionnelle de Dermatologie Cancérologie, Nates 44093, France; Not yet recruiting
Brigitte Dreno, Prof.
Brigitte Dreno, Prof., Principal Investigator

HOPITAL DE L ARCHET II - Service de Dermatologie-Vénérologie, Nice 06202, France; Not yet recruiting
Jean-Philippe Lacour, Prof.
Jean-Philippe Modiano, Prof., Principal Investigator

Hôpital Caremeau, Nimes 30029, France; Not yet recruiting
Laurent Meunier, Prof.
Laurent Meunier, Prof., Principal Investigator

HOPITAL COCHIN TARNIER - Service de Dermatologie, Paris 75006, France; Not yet recruiting
Selim Aractingi, Prof.
Selim Aractingi, Prof., Principal Investigator

Hôpital Saint Louis - Service de Dermatologie, Paris 75475, France; Not yet recruiting
Nicole Basset-Seguin, Prof.
Nicole Basset-Seguin, Dr., Principal Investigator

CHU BORDEAUX - Hôpital Haut-Lévêque, Pessac 33604, France; Not yet recruiting
Marie Beylot-Barry, Prof.
Marie Beylot-Barry, Prof., Principal Investigator

CHU Poitiers - Service de Dermatologie, Poitiers 86021, France; Not yet recruiting
Gérard Guillet, Prof.
Gérard Guillet, Prof., Principal Investigator

C.H.U. de Saint-Etienne - Hôpital Nord, Saint-Etienne 42055, France; Not yet recruiting
Frédéric Cambazard, Prof.
Frédéric Cambazard, Prof., Principal Investigator

Hôpital d'instruction des Armées Bégin - Clinique Dermatologique, St Mandé 94160, France; Not yet recruiting
Michel Dupin, Dr.
Michel Dupin, Dr., Principal Investigator

Hautarztpraxis Simon, Berlin 10827, Germany; Recruiting
M Simon, Dr.med
M Simon, Dr. med., Principal Investigator

Hauttumorzentrum Bochum Universitätsklinikum der Ruhr-Universität-Bochum, Bochum 44791, Germany; Recruiting
N Lahner, Dr. med
N Lahner, Dr. med., Principal Investigator

Praxis Streit Bucholz, Buchholz 21244, Germany; Recruiting
V Streit, Dr. med
V Streit, Dr. med., Principal Investigator

Dermatologisches Zentrum, Am Krankenhaus 1, Buxtehude 21614, Germany; Not yet recruiting
P Mohr, MD
P Mohr, Dr.med, Principal Investigator

Klinikum Dortmund - Hautklinik, Dortmund 44137, Germany; Recruiting
D Nashan, Prof. Dr.med
D Nashan, Prof. Dr.med., Principal Investigator

Mensingderma, Hamburg 22391, Germany; Recruiting
C Mensing, Dr.
C Mensing, Dr., Principal Investigator

Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie, Leipzig 04103, Germany; Recruiting
J C Simon, Prof. Dr. med.
J C Simon, Prof. Dr.med, Principal Investigator

Hautpraxis Dr. Ina Schulze, Markkleeberg 04416, Germany; Recruiting
I Schulze, Dr.med.
I Schulze, Dr.med., Principal Investigator

Hauttumorzentrum Münster, Münster 48149, Germany; Not yet recruiting
C Weishaupt
C Weishaupt, Dr.med., Principal Investigator

Klinik für Dermatologie und Allergologie, Klinikum Vest, Behandlungszentrum, Knappschaftskrankenhaus Recklinghausen,, Recklinghausen 45657, Germany; Recruiting
R M Szeimies, Prof. Dr.med
R M Szeimies, Prof. Dr.med, Principal Investigator

Universitätklinikum Regensburg, Regensburg 93053, Germany; Not yet recruiting
S Karrer, Prof. Dr.med.
S Karrer, Prof. Dr.med, Principal Investigator

Praxis Dr. Hoffmann, Witten 58453, Germany; Recruiting
M Hoffmann, Dr. med.
M Hoffmann, Dr.med., Principal Investigator

Praxis Derma Hübinger, Wuppertal 42105, Germany; Recruiting
F Hübinger, Dr.med.
F Hübinger, Dr.med., Principal Investigator

Universitätsklinikum Würzburg, Würzburg 97080, Germany; Recruiting
H Hamm, Prof. Dr.
H Hamm, Prof.Dr., Principal Investigator

Hull Royal Infirmary, Hull, United Kingdom; Not yet recruiting
S Walton
S Walton, MD, Principal Investigator

Ninewells Hospital, Dundee, Angus, United Kingdom; Recruiting
C Proby, MD
C Proby, MD, Principal Investigator

Cumberland Infirmary, Carlisle, Cumbria, United Kingdom; Recruiting
M Nik, MD
M Nik, MD, Principal Investigator

Heavitree Hospital, Exeter, Devon, United Kingdom; Recruiting
A Downs
A Downs, MD, Principal Investigator

Brighton General Hospital, Borough of Brighton and Hove, East Sussex, United Kingdom; Recruiting
C DeGiovanni, MD
C DeGiovanni, MD, Principal Investigator

Manchester Royal Infirmary, Manchester, Greater Manchester, United Kingdom; Recruiting
J Lear, MD
J Lear, MD, Principal Investigator

Monklands Hospital, Airdrie, Lanarkshire, United Kingdom; Recruiting
G Gupta, MD
G Gupta, MD, Principal Investigator

Scunthorpe General Hospital, Scunthorpe, Lincolnshire, United Kingdom; Recruiting
A Butt, MD
A Butt, MD, Principal Investigator

Royal Gwent Hospital, Newport, Monmouthshire, United Kingdom; Recruiting
A Anstey, MD
A Anstey, MD, Principal Investigator

Harrogate District Hospital, Harrogate, North Yorkshire, United Kingdom; Not yet recruiting
A M Layton, MD
A M Layton, MD, Principal Investigator

Scarborough Hospital, Scarborough, North Yorkshire, United Kingdom; Recruiting
C Lyon, MD
C Lyon, MD, Principal Investigator

Cannock Chase Hospital, Cannock, Staffordshire, United Kingdom; Recruiting
S Cheung, MD
S Cheung, MD, Principal Investigator

East Surrey Hospital, Redhill, Surrey, United Kingdom; Recruiting
S Cliff, MD
S Cliff, MD, Principal Investigator

Southlands Hospital, Shoreham-by-Sea, West Sussex, United Kingdom; Recruiting
A Woollons, MD
A Woollons, MD, Principal Investigator

St Luke's Hospital, Bradford, West Yorkshire, United Kingdom; Recruiting
A Wright, MD
A Wright, MD, Principal Investigator

Chapel Allerton Hospital, Leeds, West Yorkshire, United Kingdom; Not yet recruiting
M Goodfield, MD
M Goodfield, MD, Principal Investigator

Additional Information

Starting date: September 2013
Last updated: March 6, 2015

Page last updated: August 23, 2015

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