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    Summary
    EudraCT Number:2016-004635-20
    Sponsor's Protocol Code Number:P1605NY
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-004635-20
    A.3Full title of the trial
    A monocentric, randomized, controlled, investigator-blind trial to evaluate the efficacy and safety of an investigational medical device (PB790) in subjects with head lice.
    Monozentrische, randomisierte, kontrollierte, Prüfer-verblindete, Vergleichsstudie zur Bestimmung der Sicherheit und Wirksamkeit des Medizinprodukts PB790 in Patienten mit Kopfläusen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and safety of an investigational medical device (PB790) in subjects with head lice.
    Vergleichsstudie zur Bestimmung der Sicherheit und Wirksamkeit des Medizinprodukts PB790 in Patienten mit Kopfläusen.
    A.3.2Name or abbreviated title of the trial where available
    PB790 in Head Lice
    PB790 bei Kopfläusen
    A.4.1Sponsor's protocol code numberP1605NY
    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 SponsorG. Pohl-Boskamp 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 supportG. Pohl-Boskamp GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardioSec Clinical Research GmbH
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressDalbergsweg 21
    B.5.3.2Town/ cityErfurt
    B.5.3.3Post code99084
    B.5.3.4CountryGermany
    B.5.4Telephone number4936178919740
    B.5.5Fax number4936178919744
    B.5.6E-mailinfo@cardiosec.de
    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 InfectoPedicul
    D.2.1.1.2Name of the Marketing Authorisation holderINFECTOPHARM Arzneimittel und Consilium 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 nameInfectoPedicul
    D.3.4Pharmaceutical form Cutaneous liquid
    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 INNPermethrin
    D.3.9.3Other descriptive namePERMETHRIN BPC CIS:TRANS/ 25:75
    D.3.9.4EV Substance CodeSUB72832
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.3
    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
    Headlice infestation
    E.1.1.1Medical condition in easily understood language
    Headlice
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10019197
    E.1.2Term Head lice
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of efficacy of medical device PB790 for the treatment of head lice in comparison to reference InfectoPedicul
    E.2.2Secondary objectives of the trial
    Evaluation of safety and efficacy of PB790 in comparison to InfectoPedicul
    Assesment of:
    global tolerability
    skin irritation
    eyes irritation
    satisfection with esthetical effects
    safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible, the following inclusion criteria must be met:
    1. Gender: male/female
    2. Age: > =2 years of age at the time of signing the informed consent
    3. Patients with active head lice infestation of at least 5 live lice
    4. Patient or his/her guardian must be capable of understanding and providing written informed consent
    5. The patient or his/her legal representative must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
    6. Patients must agree to not use any other ant-lice treatment for the duration of the study
    7. Female patients:
    are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel
    -or

    are women of non–childbearing potential, defined as: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation),
    -or
    women who are ≥60 years of age.
    E.4Principal exclusion criteria
    A participant is not eligible, if any of the following exclusion criteria are present:
    1. Known allergic reactions or hypersensitivity to the active ingredients used or the constituents
    2. Patients with known skin allergies, multiple drug allergies or multiple allergies to cosmetic products
    3. Pregnant or breast feeding women
    4. Patient underwent treatment with any form of head lice treatment within the last 30 days prior to the Screening Visit (day 0)
    5. Patients with severe acute scalp disorder
    6. Patients with hair longer than mid-back
    7. Individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
    8. Patients suspected or known not to follow instructions
    9. Patients or his/her legal representative who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
    10. Previous participation in this study or participation in any other investigational trial within the preceding 30 days
    11. The patients are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    12. The patients are G. Pohl-Boskamp employees or are employees of third-party organizations involved in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Cure rate at the end of day 10 (corrected for re-infestation) for the test product PB 970 for all baseline infestations
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 10
    E.5.2Secondary end point(s)
    Difference of cure rates (as defined as primary endpoints)
    Local tolerability by patient: subjective symptoms (burnng, Paraesthesia, pruritus):0h, 1h,24h, 7d and 10d p.a. (descriptive evaluation)
    Global tolerability by the patient and study staff (number of subjects with global tolerability ratings of "very good", "good", "moderate", "poor", descriptive evaluation) at 10d after application
    Evluation of skin irritation post-treatment by study staff (secondary infection, erythema, excoriation)
    Evaluation of eye irritation on day 0,1,7,10
    Characterisation of safety and tolerability of the investigational products considering Adverse Events in the study population
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cure rate: study day 1 and 7

    scalp itching, skin irritation, eye irritation: baseline, 0h (direct after application, h, 24h, 7d,10d p.a.

    local tolerability, adverse events: 0h (direct after application, 1h, 24h, 7d, 10d p.a.

    global tolerability: 10d p.a.
    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 No
    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) 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
    InfectoPedicul is the comparator, medical device PB790 ist the test product
    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.8.5The 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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 70
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 55
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children, adolescents
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    In case final examination shows actice head lice infestation (living nymph or imago) the patient will be referred to his GP for further treatment
    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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
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