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    Summary
    EudraCT Number:2010-022054-16
    Sponsor's Protocol Code Number:X-03016-3284
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-06
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-022054-16
    A.3Full title of the trial
    Long-term effects of Aldara® 5% cream and
    Solaraze® 3% gel in the treatment of actinic keratoses
    on the face or scalp with respect to the risk of
    progression to in-situ and invasive squamous cell
    carcinoma (LEIDA 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term effects of Aldara® 5% cream compared to
    Solaraze® 3% gel in the treatment of actinic keratoses
    on the face or scalp.
    A.3.2Name or abbreviated title of the trial where available
    LEIDA 2
    A.4.1Sponsor's protocol code numberX-03016-3284
    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 SponsorMEDA Pharma GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportMEDA Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSIRO Clinpharm Germany GmbH
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressKaiserstr. 39
    B.5.3.2Town/ cityOffenbach am Main
    B.5.3.3Post code63065
    B.5.3.4CountryGermany
    B.5.4Telephone number++4969850933849
    B.5.5Fax number++4969850933883
    B.5.6E-mailBaerbel.Fingerhut@siroclinpharm.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 Yes
    D.2.1.1.1Trade name Aldara® 5% cream
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Cream
    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 INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.2Current sponsor codeIMIQ
    D.3.9.3Other descriptive name1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4 amine
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Solaraze® 3% gel
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Almirall S.A.
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.4Pharmaceutical 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.3.9.1CAS number 15307-79-6
    D.3.9.2Current sponsor codeDIC
    D.3.9.3Other descriptive nameDICLOFENAC SODIUM
    D.3.9.4EV Substance CodeSUB01674MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This study will compare the long term effects of Aldara® and Solaraze® of the actinic keratoses on the face or scalp. Actinic keratoses (AKs) are defined as keratotic macules, papules or plaques with superficial scale on a red base, occurring on areas of extensive damage through sunlight. AKs are mainly induced by non-ionised radiation, especially through chronic UV-exposition, primarily sunlight.
    E.1.1.1Medical condition in easily understood language
    The study will compare the long term effects of Aldara® and Solaraze® of the skin disease actinic keratosis (spot-like scaly papules) 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
    The primary objective is to determine the long-term outcome with respect to the risk of progression to SCC (in situ and/or invasive) of treatment with Aldara® 5% cream (IMIQ) and Solaraze® 3% gel (DIC) with increased precision (meta-analysis with study X-03016-3271).
    E.2.2Secondary objectives of the trial
    Secondary objectives include recurrence rates, the time to recurrence, need of rescue treatment, and cosmetic outcome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Immunocompetent patient.
    2. A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area.
    3. A positive histological finding for AK grade I or II (see Section 7.1.1.2). This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory.
    4. Willingness to comply with the obligations of the study.
    E.4Principal exclusion criteria
    1. History of hypersensitivity to imiquimod, diclofenac, acetyl salicylic acid, other non-steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.
    2. Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly
    such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
    Lack of suitability for the study:
    3. Presence of AK lesions in the STA with clinically excessive hyperkeratosis as seen in cutaneous horns.
    4. Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation.
    5. Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.
    6. Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
    7. Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
    8. Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).
    9. Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.
    10. History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).
    11. History of any malignant skin tumour having metastasised or in which metastasis within the study period is likely.
    12. History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years which might hinder regular treatment and supervision and might lead to premature withdrawal from the study.
    13. Mentally incapacitated patient.
    14. Present or history of drug or alcohol abuse within the last 3 years.
    Administrative reasons:
    15. Exposure to an investigational product within the last 3 months.
    16. Lack of ability or willingness to give informed consent.
    17. Age below 18 years.
    18. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
    19. Anticipated non-availability for study visits/procedures.
    20. Vulnerable subjects (such as persons kept in detention).
    E.5 End points
    E.5.1Primary end point(s)
    The histological finding of an in situ SCC or an invasive SCC after start of treatment will be considered as “histological progression”, which is the primary efficacy variable (”endpoint”).
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 weeks after start of each treatment cycle until month 36.
    E.5.2Secondary end point(s)
    2) Histological classification.
    3) Recurrence with respect to the study treatment area. A patient is classified as recurrent when cleared at Visit Week 20 and having later on at least one clinically diagnosed AK lesion in the STA.
    4) Incidence of withdrawals from study treatment due to lack of efficacy.
    5) Percent clinical clearance (complete = 100%, partial = 75%, and individual clearance) of baseline AK lesions in the study treatment area 8 weeks after end of treatment and at Week 20.
    6) Lesion clearance 8 weeks after end of treatment and at Week 20.
    7) Number of treatment cycles per patient in the STA during the study.
    8) Number of patients with cryotherapy in the STA during the study.
    9) Number of cryotherapies in the STA by patient.
    10) Total number of lesions treated with cryotherapy in the STA during the study.
    11) Cosmetic outcome (investigator and patient) at Week 20 and then at Month 12, 18, 24, 30 and 36.
    12) Local skin reactions.
    13) Adverse events of special interest.
    14) Other adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2) 20 weeks after start of each treatment cycle until month 36.
    3,7) at least half-yearly until m36.
    4,8,9,10) at any visit until m36.
    5,6) 8 weeks after end of treatment and at Week 20.
    11) at Week 20 and then at at least half-yearly until m36.
    12,13,14) at each visit until m36.
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 220
    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)
    The Investigator is free to choose any treatment after excision of an invasive SCC, after Month 36, or after premature discontinuation.
    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 Decision2011-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-27
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