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

August 10, 2020 updated by: LEO Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU Angers - Service de Dermatologie
      • Besançon, France, 25030
        • CHU Besançon - Hôpital Jean Minjoz
      • Bobigny, France, 93009
        • HOPITAL AVICENNE - Service de Dermatologie
      • Brest, France, 29609
        • CHRU de Brest - Hôpital Morvan - Service de Dermatologie
      • Grenoble, France, 38043
        • CHU Albert Michallon - Service de Dermatologie, Pôle Pluridisciplinaire de Médecine
      • Lille, France, 59037
        • Hôpital Claude Huriez - CHRU de Lille - Clinique de Dermatologie
      • Marseille, France, 13385
        • Hôpital de la Timone - Service de Dermatologie Vénérologie
      • Nantes, France, 44093
        • CHU de Nantes - Hôtel Dieu - Unité Fonctionnelle de Dermatologie Cancérologie
      • Nice, France, 06202
        • HOPITAL DE L ARCHET II - Service de Dermatologie-Vénérologie
      • Nimes, France, 30029
        • Hopital Caremeau
      • Paris, France, 75475
        • Hôpital Saint Louis - Service de Dermatologie
      • Paris, France, 75006
        • HOPITAL COCHIN TARNIER - Service de Dermatologie
      • Pessac, France, 33604
        • CHU Bordeaux - Hopital Haut-Leveque
      • Poitiers, France, 86021
        • CHU Poitiers - Service de Dermatologie
      • Saint-Etienne, France, 42055
        • C.H.U. de Saint-Etienne - Hôpital Nord
      • St Mandé, France, 94160
        • Hôpital d'instruction des Armées Bégin - Clinique Dermatologique
  • Germany
      • Berlin, Germany, 10827
        • Hautarztpraxis Simon
      • Bochum, Germany, 44791
        • Hauttumorzentrum Bochum Universitätsklinikum der Ruhr-Universität-Bochum
      • Buchholz, Germany, 21244
        • Praxis Streit Bucholz
      • Buxtehude, Germany, 21614
        • Dermatologisches Zentrum, Am Krankenhaus 1
      • Dortmund, Germany, 44137
        • Klinikum Dortmund - Hautklinik
      • Hamburg, Germany, 22391
        • Mensingderma
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie
      • Markkleeberg, Germany, 04416
        • Hautpraxis Dr. Ina Schulze
      • Münster, Germany, 48149
        • Hauttumorzentrum Münster
      • Recklinghausen, Germany, 45657
        • Klinik für Dermatologie und Allergologie, Klinikum Vest, Behandlungszentrum, Knappschaftskrankenhaus Recklinghausen,
      • Regensburg, Germany, 93053
        • Universitätklinikum Regensburg
      • Witten, Germany, 58453
        • Praxis Dr. Hoffmann
      • Wuppertal, Germany, 42105
        • Praxis Derma Hübinger
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • United Kingdom
      • Hull, United Kingdom
        • Hull Royal Infirmary
    • Angus
      • Dundee, Angus, United Kingdom
        • Ninewells Hospital
    • Cumbria
      • Carlisle, Cumbria, United Kingdom
        • Cumberland Infirmary
    • Devon
      • Exeter, Devon, United Kingdom
        • Heavitree Hospital
    • East Sussex
      • Brighton, East Sussex, United Kingdom
        • Brighton General Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom
        • Manchester Royal Infirmary
    • Lanarkshire
      • Airdrie, Lanarkshire, United Kingdom
        • Monklands Hospital
    • Lincolnshire
      • Scunthorpe, Lincolnshire, United Kingdom
        • Scunthorpe General Hospital
    • Monmouthshire
      • Newport, Monmouthshire, United Kingdom
        • Royal Gwent Hospital
    • North Yorkshire
      • Harrogate, North Yorkshire, United Kingdom
        • Harrogate District Hospital
      • Scarborough, North Yorkshire, United Kingdom
        • Scarborough Hospital
    • Staffordshire
      • Cannock, Staffordshire, United Kingdom
        • Cannock Chase Hospital
    • Surrey
      • Redhill, Surrey, United Kingdom
        • East Surrey Hospital
    • West Sussex
      • Shoreham-by-Sea, West Sussex, United Kingdom
        • Southlands Hospital
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom
        • St Luke's Hospital
      • Leeds, West Yorkshire, United Kingdom
        • Chapel Allerton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: 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.
Other Names:
  • Picato®
ACTIVE_COMPARATOR: 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
Drug: Imiquimod Cream, 5%
Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Other Names:
  • Aldara®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SCC
Time Frame: 3 years
Cumulative incidence of SCC after treatment with ingenol mebutate gel and imiquimod cream.> The primary response criterion is diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period.> Kaplan-Meier estimate based on time to SCC or censoring.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SCC and Other Neoplasia
Time Frame: 3 years
Cumulative incidence of SCC and other neoplasia after treatment with ingenol mebutate gel and imiquimod cream.> The secondary response criterion is diagnosis of SCC and other neoplasia in the treatment field across the 3-year trial period.> Kaplan-Meier estimate based on time to SCC and other neoplasia, or censoring.
3 years
Number of Participants With Complete Clearance of AK Lesions After Last Treatment
Time Frame: 8-16 weeks
To compare the complete clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16)
8-16 weeks
Number of Participants With Partial Clearance of AK Lesions
Time Frame: 8-16 weeks
To compare the partial (at least 75%) clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16)
8-16 weeks
Number of Participants With Complete Clearance of AK Lesions at 12 Months
Time Frame: 1 year
To compare the complete clearance of AK lesions at 12 months, defined as no AK lesions in the selected treatment area at any time from the last treatment cycle at Week 8 or 16 through to Month 12.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Rolf-Markus Szeimies, Prof.Dr.med., Klinik für Dermatologie und Allergologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 11, 2013

Primary Completion (ACTUAL)

July 11, 2019

Study Completion (ACTUAL)

July 11, 2019

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (ESTIMATE)

August 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0041-63
  • 2012-003112-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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