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    Summary
    EudraCT Number:2015-002451-10
    Sponsor's Protocol Code Number:LP0084-1195
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-002451-10
    A.3Full title of the trial
    Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp including 12-month follow-up
    Part 1: 3-day treatment period including an 8-week follow-up period
    Part 2: extended 12-month follow-up period
    A phase 3, multi-centre, randomised, parallel group, double-blind, vehicle controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis (sun spots) on Balding Scalp including 12-month follow-up
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberLP0084-1195
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02547363
    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.1.3.4CountryUnited States
    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.4.2CountryDenmark
    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 pointMohammed Alif
    B.5.3 Address:
    B.5.3.1Street AddressLEO Pharma Inc. 1 Sylvan Way
    B.5.3.2Town/ cityParsippany
    B.5.3.3Post codeNJ 07504
    B.5.3.4CountryUnited States
    B.5.4Telephone number001877494 4536
    B.5.5Fax number001973 637 1690
    B.5.6E-mailmdaus@leo-pharma.com
    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 nameLEO 43204 Gel
    D.3.2Product code LEO 43204 Gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    E.1.1.1Medical condition in easily understood language
    Sun spots
    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 19.0
    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 confirm the efficacy of LEO 43204 gel (0.037% for scalp) in AK when applied topically once daily for three consecutive days as field treatment
    E.2.2Secondary objectives of the trial
    To evaluate the safety of LEO 43204 gel (0.037% for scalp) in AK when applied topically once daily for three consecutive days as field treatment

    To evaluate the long term efficacy of LEO 43204 gel (0.037% for scalp) in AK in an extended 12-month follow-up period after initial complete clearance at Week 8
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent has been obtained.
    2. Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 in2).
    3. For subjects with a treatment area greater than or equal to 50 cm2 (8 in2) a tracking area of 50 cm2 (8 in2), with a minimum of 3 clinically typical, visible and discrete AKs, will be identified. The tracking area must be within the treatment area. If the treatment area is less than 50 cm2, the tracking area will be reduced and will be the same as the treatment
    area.
    4. Subjects at least 18 years of age.
    5. Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
    Female subjects are considered of childbearing potential unless they have been hysterectomised or have undergone tubal ligation or have been post-menopausal for at least one year prior to first visit.
    6. Female subjects of child-bearing potential must be willing to use effective contraception
    at trial entry and until Visit 7.
    Effective contraception is defined as follows:
     Abstinence (when this is in line with the preferred and usual life style of the subject).
     Vasectomised partner (given that the subject is monogamous).
     An intrauterine device.
     Double barrier method defined as two distinct methods (two actual barrier methods).
     Hormonal contraceptive (oral hormonal birth control, oestrogenic vaginal ring, percutaneous contraceptive patches, implants and injectables) for at least one menstrual cycle prior to enrolment
    E.4Principal exclusion criteria
    1. Location of the treatment area (full balding scalp)
     within 5 cm of an incompletely healed wound
     within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
    2. Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme (presently LP0084-68, LP0084-1013, LP0084-1014, LP0084-1015, LP0084-1148, LP0084-1077, LP0084-1193, LP0084-1194, LP0084-1196).
    3. Treatment with ingenol mebutate gel in the treatment area within the last 12 months.
    4. Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 30 days.
    5. Lesions in the treatment area that have: atypical clinical appearance (e.g. hypertrophic, hyperkeratotic or cutaneous horns) and/or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions).
    6. History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum).
    7. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment area.
    8. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a severe AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgement.
    9. Any abnormal laboratory tests that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.
    10. Subjects known to be infected with Human Immunodeficiency Virus (HIV).
    11. Subjects with any hematological malignancies.
    12. Male subjects with QTcF interval > 450 ms and female subjects with QTcF interval > 470 ms). Other abnormal ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator. The QTcF intervals are not relevant for subjects with cardiac pacemaker.
    13. Known sensitivity or allergy to any of the component(s) of the IP.
    14. Presence of acute sunburn within the treatment area.
    15. Current participation in any other interventional clinical trial.
    16. Female subjects who are breastfeeding.
    17. Subjects who in the opinion of the investigator, are unlikely to comply with the clinicaltrial protocol (e.g. due to alcoholism, drug dependency or psychotic state).
    18. Close affiliation with the investigator (e.g. a close relative) or persons working at the trialsites or subject is an employee of the sponsor.
    Prohibited Therapies and/or Medications within 2 weeks prior to Visit 2/Day 1:
    19. Cosmetic or therapeutic procedures (e.g. use of liquid nitrogen, surgical excision,curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 cm of the treatment area.
    20. Use of topical keratolytic therapeutic products (e.g. alpha- and beta- hydroxy acids, including glycolic acid, lactic acid and other fruit acids, salicylic acid, topical retinoids, urea or light chemical peels): within 2 cm of the treatment area.
    21. Use of topical medicated creams, ointments, lotions, gels, foams or sprays (including topical steroids and topical methotrexate): within 2 cm of the treatment area; artificial tanners: within 5 cm of the treatment area.
    Note: non-medicated/non-irritant lotions/creams/sunscreens are acceptable on the treatment area until within 3 days of Visit 2/Day 1.
    Prohibited Therapies and/or Medications: within 4 weeks prior to Visit 2/Day 1:
    22. Treatment with systemic chemotherapeutic antineoplastic therapy.
    23. Treatment with systemic medications that suppress the immune system (e.g. cyclosporine,prednisone). Note: inhaled, nasal, intra-articular, ophthalmic and intra-auricular corticosteroids are permitted.
    24. Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB).
    25. Treatment with imiquimod or photodynamic therapy (PDT) within 2 cm of the treatment area.
    E.5 End points
    E.5.1Primary end point(s)
    Complete clearance at Week 8, defined as no clinically visible AKs in the treatment area
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    -Partial clearance at Week 8, defined as at least 75% reduction in the number of clinically
    visible AKs in the treatment area
    -Partial clearance at Week 4, defined as at least 75% reduction in the number of clinically
    visible AKs in the treatment area
    -Percent reduction in AK count in the treatment area at Week 8 compared to baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Week 8
    -Week 4
    -Week 8
    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.7.1.3.1Other 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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Canada
    France
    United Kingdom
    United States
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days17
    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: 153
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 153
    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 state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 306
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NIHR CRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-06
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