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    Summary
    EudraCT Number:2014-001218-24
    Sponsor's Protocol Code Number:TDL-CS-001
    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:2014-04-15
    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 number2014-001218-24
    A.3Full title of the trial
    An open label, intra-subject, controlled multi-centre study to assess the concordance (specificity and sensitivity) between Colourstart® Test 73 mcg Cutaneous Patch and Finn Chamber in the detection of para-Phenylenediamine (PPD) allergy in subjects with known or clinically suspected allergy and those with no known allergy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see how well the Colourstart skin test patch identifies PPD allergy compared with Finn Chamber
    A.3.2Name or abbreviated title of the trial where available
    Colourstart® Test 73 mcg Cutaneous Patch. TDL-CS-001
    A.4.1Sponsor's protocol code numberTDL-CS-001
    A.5.4Other Identifiers
    Name:CCRNNumber:2722
    Name:CSPIDNumber:146280
    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 SponsorTrichocare Diagnostics Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportTechnology Strategy Board
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNick Plunkett
    B.5.2Functional name of contact pointManaging Director
    B.5.3 Address:
    B.5.3.1Street AddressBerry End Farmhouse
    B.5.3.2Town/ cityEversholt
    B.5.3.3Post codeMK17 9EB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01525288881
    B.5.6E-mailnick.plunkett@trichocare.co.uk
    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 Colourstart® Test 73 mcg Cutaneous Patch
    D.2.1.1.2Name of the Marketing Authorisation holderTrichocare Diagnostics Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Plaster for provocation test
    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 INNPara-Phenylenediamine
    D.3.9.1CAS number 106-50-3
    D.3.9.2Current sponsor codeSUB15001MIG
    D.3.9.3Other descriptive namePPD
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit cm2 square centimeter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    Para-Phenylenediamine allergy
    E.1.1.1Medical condition in easily understood language
    PPD allergy
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10065649
    E.1.2Term PPD skin test positive
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does Colourstart successfully identify those subjects who are Finn Chamber negative from those who are Finn Chamber positive and at most potential risk from exposure to hair dye containing PPD?
    E.2.2Secondary objectives of the trial
    Can consumers accurately read the results of the Colourstart test?
    How easy is Colourstart to use?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To qualify for the study a subject must:
    1. Be male or female aged 18 years and over and be judged to be in good general health
    2. a. Have either a known allergy to PPD (defined as a clear positive diagnostic test response to PPD combined with relevant or past history consistent with PPD allergy); or have a clinically suspected allergy to PPD (defined as a relevant current or past history consistent with PPD allergy [including subjects with a history of reactions to temporary black henna tattoos], as assessed by a dermatologist or general practitioner)

    OR
    b. Have no known allergy to PPD (defined as no documented evidence of PPD allergy from exposure to any relevant product or any clinical suspicion of PPD allergy)
    3. Have had no febrile or infectious illness for at least seven days prior to the first administration of the investigational product
    4. If female be practicing one or a combination of the following methods of birth control: hormonal contraceptives, condoms, sponge, foams, jelly, diaphragm, or intrauterine device or women who are surgically sterilized or are post-menopausal
    5. Voluntarily sign and date an informed consent document, approved by Research Ethics Committee, indicating that the subject has been informed of all aspects of the trial
    6. Be willing and able to undergo all test procedures and attend all study visits
    E.4Principal exclusion criteria
    A subject will be excluded from study participation if they:
    1. Have any visible skin disorder, abnormal skin pigmentation, multiple birth marks or significant hair growth in the test area which, in the opinion of the investigator, would interfere with the conduct of the trial
    2. Have any acute or chronic dermatological condition in the test area that precludes the evaluation of any reaction or would in any way confound interpretation of the study results, including a. rash, atopic dermatitis, eczema or acne,
    b. erythema, eschar or excoriation
    c. scars or existing tattoos
    d. sunburn or injury of the skin

    3. Have a known allergy to adhesive tape

    4. Use any emollient or other topical dermatological preparation in the test area that cannot be stopped for the duration of the study

    5. Have had exposure to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to Day 0 or planned during the study period

    6. Have a history of or known allergy or drug hypersensitivity which is severe or life threatening (e.g. associated with anaphylaxis, angio-oedema, respiratory distress etc.). Note: subjects with allergic contact dermatitis associated with other allergens (e.g. nickel, gold) are not excluded provided it is not severe or life threatening

    7. Have a history of any acute or unstable chronic disease that in the opinion of the investigator might interfere with the interpretation of the study results or increase the risk of study participation (e.g. systemic lupus erythematosus, rheumatoid arthritis, other autoimmune diseases, asthma and other chronic respiratory disease)

    8. Have a history of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

    9. Have been treated within 4 weeks prior to Day 0 or require treatment with
    a. topical and/or systemic corticosteroids and/or other immunosuppressive drugs, or
    b. any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk

    10. Have received immunisation/s within 4 weeks of the Day 0 visit

    11. Cannot avoid, throughout the duration of the trial, any swimming, any washing of the upper arm, or sauna or any intense physical activity that might result in excessive sweating

    12. Are female and are pregnant, or trying to become pregnant, or are breast feeding at Screening or during the trial
    13. Have participated in the treatment phase of a clinical trial within 30 days prior to the treatment phase of this trial or within 10 times the respective elimination half-life of the investigational drug
    14. Are an employee of the sponsor or members of their immediate family
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the specificity and sensitivity of Colourstart compared to Finn Chamber as assessed by positive or negative skin reaction readings by the investigator at 48 hours post application.

    The following variables comprise the primary endpoint:
    • Colourstart application site reaction reading at 48 hours post application by the investigator (negative reaction or positive reaction)
    • Finn Chamber application site reaction reading at 48 hours post application by the investigator (negative reaction or positive reaction)

    The primary endpoint is the specificity and sensitivity of Colourstart compared to Finn Chamber as assessed by positive or negative skin reaction readings by the investigator at 48 hours post application.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours post application
    E.5.2Secondary end point(s)
    1. The specificity and sensitivity of Colourstart compared to Finn Chamber as assessed by positive or negative skin reaction readings by the investigator at 96 hours post application.
    2. The proportion of late responders with Colourstart and Finn Chamber as assessed by positive or negative skin reaction readings by the investigator at 48 hours compared to 96 hours post application.
    3. The degree of concordance between the subject and investigator positive or negative skin reaction readings with Colourstart as assessed at 48 hours and 96 hours post application.
    4. The proportion of late responders for Colourstart as assessed by positive or negative skin reaction readings by the subject at 48 hours compared to 96 hours post application.
    5. A comparison of graded skin reaction readings (ICDRG 0, ?, 1+, 2+ or 3+) with Colourstart versus Finn Chamber as assessed by the investigator at 48 hours and 96 hours post application.
    6. The ease of use of Colourstart (application at 0 hours and removal at 48 hours) by subjects measured using a Likert-Type Scale (Level of Difficulty).
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 and 96 hours as applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Intra-subject paired testing
    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
    Finn chamber filled with petrolatum containing 1% PPD
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state240
    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)
    All participants will receive a telephone call 14 days after trial commencement. Subjects with known PPD allergy will receive ongoing treatment as required with their condition.
    Subjects with no previously known PPD allergy who have a positive Finn Chamber test will be referred to a dermatologist for appropriate further testing and management.
    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 Comprehensive Clinical Research Network
    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 Decision2014-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-03-28
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