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    The EU Clinical Trials Register currently displays   37217   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
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    EudraCT Number:2011-005018-13
    Sponsor's Protocol Code Number:LP0041-22
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-19
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2011-005018-13
    A.3Full title of the trial
    Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberLP0041-22
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLEO Pharma A/S
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLEO Pharma A/S
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEO Pharma A/S
    B.5.2Functional name of contact pointInternational Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressIndustriparken 55
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post codeDK-2750
    B.5.4Telephone number+4544 94 58 88
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameingenol mebutate gel
    D.3.2Product code PEP005
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNingenol mebutate
    D.3.9.1CAS number 75567-37-2
    D.3.9.3Other descriptive name3-Angeloyl ingenol, Ingenol-3-angelate, 3-O-angeloylingenol
    D.3.9.4EV Substance CodeSUB32495
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.015
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Actinic keratosis on the face and scalp
    E.1.1.1Medical condition in easily understood language
    Actinic keratosis on the face and scalp
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that ingenol mebutate gel is efficacious in treating AKs present 8 weeks after initial field treatment (field recalcitrant) or emerging in a previously cleared field (field recurrent).

    Efficacy will be evaluated separately for the two sub-groups of “field recalcitrant” and “field recurrent”.
    E.2.2Secondary objectives of the trial
    To demonstrate that ingenol mebutate gel repeat use shows a higher complete clearance rate at Month 12 compared with single use of ingenol mebutate gel plus vehicle gel use in patients with multiple AKs on face or scalp.

    To evaluate the safety profile of ingenol mebutate gel second use compared with ingenol mebutate gel first use in patients with multiple AKs on face or scalp.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures

    2. Subjects with 4 to 8 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:
    a. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
    b. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy.

    5. Female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception (Pearl index < 1%) at study entry until completion of the Second Treatment Cycle (i.e. 8 weeks after randomisation) or until Week 44 for those subjects not randomised. These methods of contraception are defined as:
    • abstinence (when this is in line with the preferred and usual lifestyle of the subject)
    • vasectomised partner (partner should be the sole partner for the subject)
    • an intrauterine device
    • double barrier method defined as two distinct methods (either two actual barrier meth-ods or one actual barrier method and one hormonal method)
    • hormonal contraceptive (oral hormonal birth control, estrogenic vaginal ring, percuta-neous contraceptive patches, implants and injectables) for at least one menstrual cycle prior to enrolment (Day 1)
    E.4Principal exclusion criteria
    1. Location of the selected treatment area:
    • on any location other than the face or scalp
    • on the periorbital skin
    •within 5 cm of an incompletely healed wound
    • within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)

    2. Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on trunk and extremities acceptable).

    3. Selected treatment area lesions that have atypical clinical appearance.

    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 (e.g., eczema, psoriasis).

    5. Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle.

    6. Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel.

    7. Presence of sunburn within the selected treatment area

    8. Current enrolment or participation in a clinical trial within 30 days of entry into this study.

    9. Subjects previously entered first treatment in the trial.

    10. Female subjects who are breastfeeding.

    11. Subjects who are institutionalised by court order or by the local authority

    12. 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)

    E.5 End points
    E.5.1Primary end point(s)
    Complete clearance of AKs, defined as no clinically visible AKs in the selected treatment area, 8 weeks after randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation is after completion of the Second Treatment Cycle, corresponding to 8 weeks after randomisation.
    E.5.2Secondary end point(s)
    1. Complete clearance through to Month 12, defined as no clinically visible AKs and no lesions treated in the selected treatment area at any time from last treatment cycle through to Month 12.
    2. Change in AK count in the selected treatment area from randomisation to 8 weeks after randomisation.
    3. Adverse events occurring within first and second treatment cycles.
    4. Change in composite LSR score at Day 4 between first and second ingenol mebutate gel treatment cycles
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation:
    Regarding 1: Completion of the last treatment cycle at all visits through to Month 12
    Regarding 2: At randomisation and at 8 weeks after randomisation
    Regarding 3: The period from Day 1 to Day 57 in a Treatment Cycle.
    Regarding 4: Day 4 in each Treatment Cycle.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    The first treatment is opel Label: the second treatment is double blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state91
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 302
    F.4.2.2In the whole clinical trial 454
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After study completion the Subject will receive treatment, if necessary, after the investigators desecration.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-04
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