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    Summary
    EudraCT Number:2019-003150-86
    Sponsor's Protocol Code Number:V1.0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-05
    Trial 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 number2019-003150-86
    A.3Full title of the trial
    A Study to Investigate the Effect of Different Durations of Ameluz Application on Response to Treatment of Acral Actinic Keratoses
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Effect of Different Durations of Ameluz Application on Response to Treatment of Acral Actinic Keratoses
    A.3.2Name or abbreviated title of the trial where available
    Duration of Ameluz Application in Acral Actinic Keratoses
    A.4.1Sponsor's protocol code numberV1.0
    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 SponsorRoyal Cornwall Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGina Townley
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressRD&I Department
    B.5.3.2Town/ cityTruro
    B.5.3.3Post codeTR1 3LQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01872256430
    B.5.6E-mailrcht.sponsor@nhs.net
    D. IMP Identification
    D.IMP: 1
    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 Ameluz
    D.2.1.1.2Name of the Marketing Authorisation holderBiofrontera Bioscience GmbH
    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.3.1Product nameAmeluz
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5-aminolevulinic acid hydrochloride
    D.3.9.1CAS number 106-60-5
    D.3.9.2Current sponsor codeAmeluz
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number78
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Actinic keratoses
    E.1.1.1Medical condition in easily understood language
    Actinic keratosis (AK) is a pre-cancerous condition that result from sun damage of the skin. If left untreated these lesions can progress in cases to be cancerous.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish whether a longer duration of application (4 hours – currently unlicensed duration) for Ameluz (ALA) can improve the clinical outcome at 3 months of the treated AK lesions on acral sites. This is in comparison to conventional Ameluz (ALA) applied over 3 hours.
    E.2.2Secondary objectives of the trial
    To establish if the longer application times can increase the accumulation of the photosensitiser and any associated pain during light delivery. This will be achieved by the production of images of the photosensitiser accumulation using digital fluorescence imaging. Pain will be monitored with the visual analogue scale. Some patients will have multiple AKs in multiple sites including nonacral, these will be treated for the same duration due to practicality. Data for these nonacral sites treated simultaneously will be collected as additional secondary objectives. The temperature of the lesions during treatment will be recorded in case this causes variation in photosensitiser levels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patient has given written informed consent.
    2) Male or non-pregnant, non-lactating female.
    3) Age greater than 18 years.
    4) AK lesions on arms, hands, legs or feet that are practical to treat with PDT.
    E.4Principal exclusion criteria
    1) Lesions with a clinical diagnosis of Bowen’s disease, superficial, morphoeic or nodular basal cell carcinoma, squamous cell carcinoma, or melanoma as they are not the types of lesions required for investigation.
    2) Any disease which is caused or exacerbated by light, including systemic lupus erythematosus, porphyria, actinic reticuloid or xeroderma pigmentosum. Part of the clinical study will be the use of light-imaging system so any condition, which is sensitive to such instruments, will be excluded.
    3) For males and females of childbearing potential, the lack of adequate contraceptive precaution. Female patients should practice strict birth control (oestrogen-containing oral contraceptives or an IUD) throughout the trial. Only post-menopausal women (at least 2 years since the onset of the menopause) and women who have had a hysterectomy are exempt from the requirements to use birth control.
    4) Treatment in the previous 45 days with any cryotherapy, topical treatments for AK, experimental compound, an iron chelating agent, radiotherapy, chemotherapy or with any light activated therapy or any other medication, which may render the patient light sensitive (e.g. PUVA).
    5) Photodynamic therapy treatment in the previous 90 days.
    6) Co-existing ophthalmic disease likely to require slit lamp examination within 30 days of PDT treatment.
    7) Known allergies to porphyrins.
    8) Patients not able to comply with study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    The odds of full clearance of individual lesions in the intervention and control groups will be compared (reported as an odds ratio with 95%CLs). The null hypothesis is that there is no difference in the odds of full clearance at 3 months between those receiving ALA for 4 hours and those for 3 hours. Analysis will use generalised estimating equations (GEEs) with an exchangeable correlation matrix to account for the clustering of lesions within individuals. There are no known prognostic factors and therefore analysis will be unadjusted.

    A frequency table of clearances of acral lesions (full, partial or none) will be given by treatment arm and grade of lesion.

    The intra-class correlation coefficient will be reported for the primary outcome to assist planning of any future trials.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data will be collected at three months following PDT treatment in a clinic by a blinded assessor. It is anticipated that the data will be analysed on completion of data collection.
    E.5.2Secondary end point(s)
    1. Clearance of nonacral lesions
    The analysis specified above (primary outcome) will be repeated for any nonacral lesions as a secondary outcome.

    2. Pain assessment
    Summary statistics of pain levels (mean, sd, 95% CL or medians and interquartile ranges) will be provided between treatment arms. A t-test across arms (or a nonparametric alternative if necessary) will be carried out on the pain scores.

    A descriptive analysis (means, sds) comparing pain across both paracetamol/non-paracetamol and intervention/control will be given.

    3. Photobleaching
    Photobleaching will be calculated as the difference in fluorescence score before and after light treatment (change score). A descriptive analysis (means, sds) comparing photobleaching between intervention/control in a continuous approach will be given.

    4. Fluorescence
    PpIX accumulation and dissipation over time (3 measurements for each lesion) will be presented graphically, grouped by participant and lesion type (acral and non-acral). Correlations between the four fluorescence measurements per trial patient will be estimated (in diseased patches: at baseline, before and after light treatment; in normal skin: at baseline).

    Fluorescence after light treatment will be compared between intervention and control groups with a random effects model. The analysis will be adjusted for baseline fluorescence, grade of lesion, and location of lesion. A change score analysis will be carried out for comparison). We will check for correlation of photobleaching with clinical response rate at three months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    It is anticipated that the data will be analysed on completion of data collection.
    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 No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Same product in trial and control arm, but left on for different duration.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    Once results analysed and disseminated to relevant parties.
    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 months2
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state74
    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 drug is currently licensed for use as part of conventional NHS care. These patients enrolled in the trial are patients who would be receiving PDT treatment anyway through the NHS. Therefore after 3 months, their treatment will continue if still required through the NHS route as per standard dermatology care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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