Clinical trial NCT01926496: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis (AK)
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-08-21
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Incidence of SCC
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of SCC and Other Neoplasia
timeFrame: 3 years
measure: Number of Participants With Complete Clearance of AK Lesions After Last Treatment
timeFrame: 8-16 weeks
measure: Number of Participants With Partial Clearance of AK Lesions
timeFrame: 8-16 weeks
measure: Number of Participants With Complete Clearance of AK Lesions at 12 Months
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers - Service de Dermatologie
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Bobigny
country: France
facility: HOPITAL AVICENNE - Service de Dermatologie
city: Brest
country: France
facility: CHRU de Brest - Hôpital Morvan - Service de Dermatologie
city: Grenoble
country: France
facility: CHU Albert Michallon - Service de Dermatologie, Pôle Pluridisciplinaire de Médecine
city: Lille
country: France
facility: Hôpital Claude Huriez - CHRU de Lille - Clinique de Dermatologie
city: Marseille
country: France
facility: Hôpital de la Timone - Service de Dermatologie Vénérologie
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu - Unité Fonctionnelle de Dermatologie Cancérologie
city: Nice
country: France
facility: HOPITAL DE L ARCHET II - Service de Dermatologie-Vénérologie
city: Nimes
country: France
facility: Hôpital Caremeau
city: Paris
country: France
facility: HOPITAL COCHIN TARNIER - Service de Dermatologie
city: Paris
country: France
facility: Hôpital Saint Louis - Service de Dermatologie
city: Pessac
country: France
facility: CHU BORDEAUX - Hôpital Haut-Lévêque
city: Poitiers
country: France
facility: CHU Poitiers - Service de Dermatologie
city: Saint-Etienne
country: France
facility: C.H.U. de Saint-Etienne - Hôpital Nord
city: St Mandé
country: France
facility: Hôpital d'instruction des Armées Bégin - Clinique Dermatologique
city: Berlin
country: Germany
facility: Hautarztpraxis Simon
city: Bochum
country: Germany
facility: Hauttumorzentrum Bochum Universitätsklinikum der Ruhr-Universität-Bochum
city: Buchholz
country: Germany
facility: Praxis Streit Bucholz
city: Buxtehude
country: Germany
facility: Dermatologisches Zentrum, Am Krankenhaus 1
city: Dortmund
country: Germany
facility: Klinikum Dortmund - Hautklinik
city: Hamburg
country: Germany
facility: Mensingderma
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie
city: Markkleeberg
country: Germany
facility: Hautpraxis Dr. Ina Schulze
city: Münster
country: Germany
facility: Hauttumorzentrum Münster
city: Recklinghausen
country: Germany
facility: Klinik für Dermatologie und Allergologie, Klinikum Vest, Behandlungszentrum, Knappschaftskrankenhaus Recklinghausen,
city: Regensburg
country: Germany
facility: Universitätklinikum Regensburg
city: Witten
country: Germany
facility: Praxis Dr. Hoffmann
city: Wuppertal
country: Germany
facility: Praxis Derma Hübinger
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Angus
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
state: Cumbria
city: Exeter
country: United Kingdom
facility: Heavitree Hospital
state: Devon
city: Brighton
country: United Kingdom
facility: Brighton General Hospital
state: East Sussex
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
state: Greater Manchester
city: Airdrie
country: United Kingdom
facility: Monklands Hospital
state: Lanarkshire
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
state: Lincolnshire
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
state: Monmouthshire
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: North Yorkshire
city: Scarborough
country: United Kingdom
facility: Scarborough Hospital
state: North Yorkshire
city: Cannock
country: United Kingdom
facility: Cannock Chase Hospital
state: Staffordshire
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
state: Surrey
city: Shoreham-by-Sea
country: United Kingdom
facility: Southlands Hospital
state: West Sussex
city: Bradford
country: United Kingdom
facility: St Luke's Hospital
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
state: West Yorkshire
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
Study officials:
affiliation: Klinik für Dermatologie und Allergologie
name: Rolf-Markus Szeimies, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: