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    Summary
    EudraCT Number:2013-005338-39
    Sponsor's Protocol Code Number:n/a
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-06-21
    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 number2013-005338-39
    A.3Full title of the trial
    An assessment of intra-lesional 3% polidocanol solution in the treatment of digital myxoid cysts
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An assessment of polidocanol to treat digital myxoid cysts
    A.3.2Name or abbreviated title of the trial where available
    Polidocanol trial
    A.4.1Sponsor's protocol code numbern/a
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02154789
    A.5.4Other Identifiers
    Name:ClinicalTrials.Gov IdentifierNumber:NCT02154789
    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 SponsorUniversity of Edinburgh
    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 supportFoundation for Skin Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNHS Lothian
    B.5.2Functional name of contact pointAlex Holme
    B.5.3 Address:
    B.5.3.1Street AddressLauriston Building, Lauriston Place
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH3 9HA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01315362410
    B.5.5Fax number01315364220
    B.5.6E-mailalex.holme@nhs.net
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    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 supportFoundation for Skin Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNHS Lothian
    B.5.2Functional name of contact pointAlex Holme
    B.5.3 Address:
    B.5.3.1Street AddressLauriston Building, Lauriston Place
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH3 9HA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01315362410
    B.5.5Fax number01315364220
    B.5.6E-mailalex.holme@nhs.net
    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 Aethoxysklerol
    D.2.1.1.2Name of the Marketing Authorisation holderChemische Fabrik Kreussler & Co GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAethoxysklerol
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Digital Myxoid Cysts
    E.1.1.1Medical condition in easily understood language
    A digital myxoid cyst arises from degeneration in the connective tissue of the distal joint of the digit, commonly the finger, and is thought to result from age-related osteoarthritis.
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10068991
    E.1.2Term Digital mucous cyst
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is there a difference in the percentage of patients with cyst resolution at 6 weeks post treatment in those treated with polidocanol compared to those treated with the current conventional treatments of cryotherapy and infra-red coagulation?
    E.2.2Secondary objectives of the trial
    In those treated with polidocanol compared to cryotherapy and also compared to infra-red is there a difference in:

    1) Percentage of patients with cyst resolution at 12 and 52 weeks post initial treatment
    2) Clinically apparent scarring
    3) Procedure pain / discomfort
    4) Procedure satisfaction
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Presence of a visible Digital Myxoid Cyst affecting the distal phalynx of toes or fingers.

    Ability to give informed consent.
    E.4Principal exclusion criteria
    History of sensitivity to polidocanol or other sclerosants.
    Age less than 18.
    Inability to give informed consent.
    Inability to report side effects experienced.
    Cyst not clearly visible.
    Cyst not fluid-filled.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of this study is to determine if there is a significant difference in the proportion of patients with cyst resolution at 6 weeks post treatment in those treated with polidocanol sclerotherapy compared to cryotherapy and infra-red coagulation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be reviewed as currently standard after 6-8 weeks. All participants will be reviewed again at 12-24 weeks, with scoring of discomfort and satisfaction of those who have undergone a second treatment. All participants will be reviewed finally at about 52 weeks.
    E.5.2Secondary end point(s)
    Patient will be reviewed at 6, 12 and 52 weeks to assess for cyst resolution, failure to respond, or recurrence.

    At 6, 12 and 52 weeks the degree of any scarring will be assessed.

    At 6 weeks, subjects will asked to assess the degree of pain and discomfort experienced.

    At 6 weeks subject’s satisfaction will be assessed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects will be reviewed as currently standard after 6-8 weeks.
    All patients will be reviewed again at 12-14 weeks. All patients will be reviewed for a final time at about 52 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 No
    E.6.5Efficacy No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    cryotherapy and infra-red coagulation
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    If this study shows a difference with polidocanol, we plan to apply for polidocanol to be added to the Lothian Joint Formulary and Fife formulary for use for DMC.

    Polidocanol will be given on 1 or 2 occasions in those allocated to that group and is not considered to be an ongoing treatment. If DMC persist, patients will be offered surgical referral as per standard 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 Decision2014-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-02
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