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

NCT ID: NCT01926496

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 485 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-11
• Study Completion Date: 2019-07-11

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

Conditions

Actinic Keratosis (AK)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ingenol Mebutate

Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8

Group Type: EXPERIMENTAL

Ingenol Mebutate Gel, 0.015%

Intervention Type: DRUG

Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.

Imiquimod

Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8

Group Type: ACTIVE_COMPARATOR

Imiquimod Cream, 5%

Intervention Type: DRUG

Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs

Interventions

Ingenol Mebutate Gel, 0.015%

Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.

Intervention Type: DRUG

Imiquimod Cream, 5%

Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs

Intervention Type: DRUG

Other Intervention Names

Picato®; Aldara®

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolf-Markus Szeimies, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Dermatologie und Allergologie

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

Nîmes, , 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

Saint-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

Countries

France; Germany; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2012-003112-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LP0041-63

Identifier Type: -

Identifier Source: org_study_id