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

February 21, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
485

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 - Hôpital Haut-Lévêque
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LEO Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP0041-63
  • 2012-003112-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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