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    Summary
    EudraCT Number:2019-003481-41
    Sponsor's Protocol Code Number:CPH-201-201461
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-31
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-003481-41
    A.3Full title of the trial
    A Double-Blinded Randomized Controlled Study to Compare the Efficacy, Time to Onset, and Duration of Effect of Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the efficacy, time to onset, and duration of effect of Botulinum Type A Toxins in the treatment of glabellar frown lines
    A.4.1Sponsor's protocol code numberCPH-201-201461
    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 SponsorCroma-Pharma GmbH
    B.1.3.4CountryAustria
    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 supportCroma-PHARMA GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCroma-PHARMA GmbH
    B.5.2Functional name of contact pointSonja Hoeller
    B.5.3 Address:
    B.5.3.1Street AddressIndustriezeile 6
    B.5.3.2Town/ cityLeobendorf
    B.5.3.3Post codeAT-2100
    B.5.3.4CountryAustria
    B.5.4Telephone number+43676846868286
    B.5.5Fax number+43226268468165
    B.5.6E-mailsonja.hoeller@croma.at
    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 Botulax
    D.2.1.1.2Name of the Marketing Authorisation holderHugel
    D.2.1.2Country which granted the Marketing AuthorisationKorea, Democratic People's Republic of
    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 nameBoNT/A-DP
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum Neurotoxin Type A
    D.3.9.1CAS number 180016-51-6
    D.3.9.2Current sponsor codeBOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX
    D.3.9.3Other descriptive nameBoNT/A-DS
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 2
    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 BOTOX Cosmetic
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameBOTOX Cosmetic
    D.3.2Product code onabotulinumtoxinA
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNonabotulinumtoxinA
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeBotox Cosmetic
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    moderate to severe glabellar frown lines at maximum frown
    E.1.1.1Medical condition in easily understood language
    Moderate to severe glabellar lines
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10052609
    E.1.2Term Glabellar frown lines
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of treatment with BoNT/A-DP as defined by the percentage of responders at Week 4 (Facial Wrinkle Scale [FWS] score of 0 or 1 and a ≥ 1 point reduction in FWS score) in reducing the severity of glabellar frown lines at maximum frown (the worst appearance of upper facial lines with maximum load on the muscle; eyebrows pushed together as far as they can go) compared to treatment with Botox Cosmetic, based on independent investigator assessment and subject assessment.
    E.2.2Secondary objectives of the trial
    • To assess the percentage of different responders after a single treatment with BoNT/A-DP compared to a single treatment of Botox Cosmetic at Weeks 1, 2, 4, 8, 12 and 16, based on independent investigator and subject assessments.
    • To assess time to onset of effect after a single treatment with BoNT/-DP compared to a single treatment of Botox Cosmetic, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments.
    • To assess the duration of effect in subjects who respond after a single treatment with BoNT/A-DP or a single treatment of Botox Cosmetic, based on independent investigator and subject assessments.
    • To assess treatment satisfaction at Weeks 4, 12, and 16 using FACE-Q Satisfaction with Outcome Scale.
    • To determine the safety and presence of any adverse effects of a single treatment of BoNT/A-DP compared to a single treatment of Botox Cosmetic in the treatment of glabellar lines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 - 75 years of age, inclusive, at the time of Screening.
    • Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on GLS-I/GLS-S) as determined by in-clinic assessments by both the investigator and the subject (where: 0='none', 1='mild', 2='moderate', 3='severe').
    • Subject has a stable medical condition with no uncontrolled systemic disease.
    • Female subjects of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the course of the study.
    • Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the GLS-S), without glasses obstructing the forehead area.
    E.4Principal exclusion criteria
    • Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to Screening, or any planned treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational treatment).
    • Known hypersensitivity to either study medication or its excipients.
    • Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy.
    • Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the three months prior to Screening or planned during the study.
    o Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers, photo-rejuvenation) within 12 months prior to Screening or planned during the study.
    • Previous insertion of permanent material in the glabellar area, or planned insertion during the study.
    • Any planned or history of surgery in the glabellar area and/or canthal line area, or scars in the glabellar and/or canthal line.
    • Active skin disease/infection or irritation at the treatment area.
    • Inability to substantially lessen glabellar frown lines and or lateral canthal lines even by physically spreading them apart.
    • Use of a muscle relaxant within 2 weeks prior to Screening, or planned use during the study.
    • Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator.
    • Pregnant, breastfeeding or planning to become pregnant during the study.
    • Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to Screening or planned during the study.
    • Planned surgery with general anesthetic (use of local anesthetic outside the glabellar area is permitted).
    • Participation in another clinical study within one month of Screening and throughout the study.
    • Previous participation in another botulinum toxin aesthetic study, which involved the treatment of glabellar, lines in combination with canthal lines and/or forehead lines in the previous 18 months.
    • Chronic drug or alcohol abuse (as per investigator discretion).
    E.5 End points
    E.5.1Primary end point(s)
    • An FWS score at the Week 4 Visit of 0 or 1 and a ≥ 1 point reduction in FWS score at maximum frown relative to Baseline, based on investigator assessment.
    • An FWS score at the Week 4 Visit of 0 or 1 and a ≥ 1 point reduction in FWS score at maximum frown relative to Baseline, based on subject assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 4 after each treatment
    E.5.2Secondary end point(s)
    1. Percentage of responders with an FWS score of 0 or 1 and a ≥ 1 point reduction in FWS score at maximum frown at Weeks 1, 2, 8, 12 and 16, based on independent investigator assessment and subject assessment.
    2. Percentage of responders with an FWS score of 0 or 1 and a ≥ 2 point reduction in FWS score at maximum frown at Weeks 1, 2, 4, 8, 12 and 16, based on independent investigator and subject assessments.
    3. Percentage of responders with an FWS score of 0 or 1 and a ≥ 1 point reduction in FWS score at rest at Weeks 1, 2, 4, 8, 12 and 16, based on independent investigator and subject assessments.
    4. Time to onset of effect, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments. Onset of effect is defined as ≥ 1 point improvement in Glabellar Line Scale - Investigator (GLS-I) and Glabellar Line Scale – Subject (GLS-S) score relative to Baseline at maximum frown in glabellar lines. In addition, onset of effect will be assessed by subjects daily during the first 2 weeks after treatment, by recordings in the subject diary.
    5. For subjects who respond, duration of effect will be assessed based on independent investigator and subject assessments. Effect will be deemed to be lost when scores return to Baseline values.
    6. The FACE-Q assessment at Weeks 4, 12 and 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    time points are indicated within each endpoint above
    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 Yes
    E.6.13.1Other scope of the trial description
    Time to Onset, Duration of Effect
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Canada
    Germany
    United States
    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
    the date of last subject 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 200
    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
    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 Decision2019-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-01
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