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    Summary
    EudraCT Number:2017-004278-32
    Sponsor's Protocol Code Number:14031972
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-12-12
    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 number2017-004278-32
    A.3Full title of the trial
    Satisfaction study of split doses botulinum toxin with double frequency
    Tevredenheidsonderzoek naar een split doseringen botuline toxine met dubbele doseerfrequentie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Satisfaction study of split doses botulinum toxin with double frequency
    Tevredenheidsonderzoek naar een split doseringen botuline toxine met dubbele doseerfrequentie
    A.4.1Sponsor's protocol code number14031972
    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 SponsorFalck clinic
    B.1.3.4CountryNetherlands
    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 supportMerz pharma
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFalck clinic
    B.5.2Functional name of contact pointPieter Siebenga
    B.5.3 Address:
    B.5.3.1Street AddressFalckstraat 51
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1017 VV
    B.5.3.4CountryNetherlands
    B.5.6E-mailpieter@falckclinic.com
    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 Bocouture
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
    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 nameBocouture
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Wrinkles, fine lines
    Rimpels, fijne lijnen
    E.1.1.1Medical condition in easily understood language
    Wrinkles, fine lines
    Rimpels, fijne lijnen
    E.1.1.2Therapeutic area Not possible to specify
    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 investigate the subjects’ satisfaction over time for the treatment of glabellar frown lines (GFL), horizontal forehead lines (HFL) and lateral periorbital wrinkles, with half the stand-ard dose of NT201 administered at more frequent intervals (intervention group; 2 months interval) and the standard dose (control group; 4 months interval) measured with an elec-tronic visual analogue scale (eVAS).
    E.2.2Secondary objectives of the trial
    · To evaluate the client’s satisfaction 4 and 8 months after baseline compared with baseline for each of the treatment areas.
    · To compared the differences in client satisfaction of the intervention group com-pared with the control group during each visit for each of the different treatment ar-eas.
    · To evaluate improvement of the appearance at every study visit, using the Global Aesthetic Improvement Scale (GAIS).
    · To evaluate the wrinkle reduction using the Miravex Antera 3D imager, the Canfield Vectra H2 3D camera, and the respective Merz Aesthetics Scales.
    · To evaluate the changes in hydration, elasticity, transepidermal water loss and se-bum production in the treated areas.
    · To evaluate the impact on quality of life of clients in the intervention group and con-trol group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Males or females, 18 to 65 years of age, inclusive;
    · General good health status
    · Symmetrical rhytids on both sides of the face, expressed by a Merz Aesthetics Scales score in dynamic ≥ 2 in all treatment areas;
    · Client overall satisfaction score  2 and ≤ 8 based on the eVAS Satisfaction Scale (0-10);
    · Able to participate and willing to give informed consent and comply with the study re-strictions.
    E.4Principal exclusion criteria
    · Clients with known allergies or sensitivity to the drug or any components of the study medication;
    · Use of any agent that impedes the neuromuscular transmission, or other neuromus-cular diseases that could amplify the effects of botulinum toxin type A treatment (e.g. myasthenia gravis, excessive weakness, Eaton-Lambert syndrome, or atrophy of target muscles);
    · Previous exposure to botulinum toxin < 6 months before the first treatment;
    · Has ever received a permanent filler in the upper face, or has received a temporary filler in the upper face in the last two years;
    · Presence of an infection, or any type of skin disease, in the treatment area;
    · Presence or history of a malignancy like melanoma in the treated area;
    · Grade 4 lines in one re more of the treatment areas expressed by the Merz Aesthetic Scales;
    · Marked asymmetry of the crow’s feet by 1 point on the Merz Aesthetic Scales;
    · Females who are pregnant, planning to get pregnant during the full duration of the study, or breastfeeding.
    · Clients with body dysmorphic disorder or related diagnosis in the DSM-V.
    E.5 End points
    E.5.1Primary end point(s)
    - Satisfaction Scale - score of treatment satisfaction over time compared with baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before every treatment visit, and with the follow-up consult.
    5 times in total.
    E.5.2Secondary end point(s)
    - Satisfaction Scale – score of treatment satisfaction before Treatment 3 (after 4 months), and at the Follow-up visit (after 8 months);
    - Satisfaction Scale – difference in satisfaction score between the IG and CG for each time point;
    - Merz Aesthetics Scales in dynamic - at least one-point improvement on the Merz Aesthetic Scales in each of the treatment areas;
    - GAIS - score of at least “improved”;
    - Antera 3D camera - Wrinkle depth quantification (mm);
    - Canfield Vectra H2 – Wrinkle depth quantification (mm);
    - MoistureMeter SC Compact - quantification of increase in hydration compared to baseline in the stratum corneum of the dermis (arbitrary units) compared with baseline;
    - ElastiMeter - quantification of increase in elasticity (instant skin elasticity [N/m]) compared with baseline;
    - VapoMeter - quantification of decrease in TEWL (evaporation rate value [g/m²h]) compared with baseline;
    - SebumScale - quantification of decrease in sebum production (amount of sebum [mg/cm²]) compared with baseline;
    - BeautyQoL - change in score on QoL.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before every treatment visit, and with the follow-up consult.
    5 times in total.
    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 Yes
    E.6.13.1Other scope of the trial description
    Satisfaction
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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
    Last client last visit
    Last client last visit
    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 months6
    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: 96
    F.1.3Elderly (>=65 years) No
    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 No
    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 state96
    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)
    None
    None
    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 Decision2019-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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