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    Summary
    EudraCT Number:2013-004834-14
    Sponsor's Protocol Code Number:POLAR_2013
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-01-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-004834-14
    A.3Full title of the trial
    Treatment of port wine stains using Pulsed Dye Laser, Erbium Yag Laser and topical sirolimus in an open label pilot study (POLAR).
    Behandeling van wijnvlekken met behulp van de Pulsed Dye Laser, de Erbium Yag Laser en lokaal aanbrengen van sirolimus (POLAR).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    New treatment for port wine stains.
    Een nieuwe behandeling voor wijnvlekken.
    A.4.1Sponsor's protocol code numberPOLAR_2013
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Rapamune
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namesirolimus
    D.3.4Pharmaceutical form Cutaneous solution
    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 INNSIROLIMUS
    D.3.9.1CAS number 53123-88-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameRapamune
    D.3.9.4EV Substance CodeSUB10537MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Port Wine Stain
    E.1.1.1Medical condition in easily understood language
    Port Wine Stain
    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 evaluate and compare the efficacy of:
    1) Pulsed Dye Laser (PDL) treatment followed by topical sirolimus application after Erbium Yag (Er:Yag) laser ablation of the stratum corneum
    2) PDL treatment followed by topical sirolimus application without Er:Yag laser ablation of the stratum corneum
    3) PDL treatment only
    4) Sirolimus application only
    E.2.2Secondary objectives of the trial
    - To evaluate the improvement in quality of life;
    - To evaluate patient discomfort and pain experienced during and following treatment;
    - To evaluate patient-reported symptoms and side-effects;
    - To assess systemic sirolimus exposure after local application by measuring serum concentrations;
    - To evaluate treatment satisfaction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject has provided informed consent;
    • Subject is ≥ 18 years of age at time of screening;
    • Subject has an extra-facial homogenous PWS;
    • The PWS is large enough in size to fit one of the templates (at least 11 cm x 3 cm or 7 cm x 5
    cm);
    • Subject has not received any laser treatment of the PWS in the last 3 months (in the treatment
    area);
    • The PWS has a minimal erythema grading score of 3 (on a 4 point scale) in the opinion of the
    investigator;
    • Screening blood safety values are within normal parameters or regarded as not
    clinically significant in the opinion of the investigator.
    E.4Principal exclusion criteria
    • PWS with a nodular/hypertrophic component in the treatment area;
    • PWS on cosmetically unacceptable locations in the opinion of the investigator;
    • For women: pregnant or breast feeding during the treatment period;
    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using adequate contraceptive measures; Effective contraception is defined as either:
    o Barrier method of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicide.
    The following methods are considered more effective than the barrier method and are also acceptable:
    o Total abstinence (when this is in line with the preferred and usual lifestyle of the subject).
    o Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before participating in the study.
    o Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
    o Use of oral, injected or implanted hormonal methods of contraception or other forms, intrauterine device (IUD) or intrauterine system (IUS)
    NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago.
    • Subject is known to have immune deficiency, or is immune compromised (including immunosuppression induced by medication);
    • Known allergy to sirolimus or other constituents of the study medication;
    • Incapacitated subjects;
    • Any medical or psychiatric condition which, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage clearance of the treated area assessed colorimetrically (Minolta colorimeter).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks, 46 weeks, 94 weeks.
    E.5.2Secondary end point(s)
    - Percentage clearance of the treated area assessed by standardized digital colour image analysis.
    - Percentage clearance of the treated area assessed by photographic evaluation by an expert panel.
    - To evaluate the improvement in quality of life (DLQI);
    - Patient discomfort and pain experienced during and following treatment (VAS);
    - Patient-reported symptoms and side-effects;
    - Systemic sirolimus exposure;
    - Treatment satisfaction (0-100 scale).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks, 46 weeks, 94 weeks
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    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.8.5The 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    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 state20
    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)
    Expected normal treatment for port wine stains
    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 Decision2014-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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