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    Summary
    EudraCT Number:2010-020827-28
    Sponsor's Protocol Code Number:191622-098
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-020827-28
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects with Lateral Canthal Rhytides
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficacy and safety of BOTOX® in the treatment of facial wrinkles (crow's feet lines)
    A.3.2Name or abbreviated title of the trial where available
    Study of the efficacy and safety of BOTOX® in the treatment of facial wrinkles (crow's feet lines)
    A.4.1Sponsor's protocol code number191622-098
    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 SponsorAllergan Limited
    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 supportAllergan Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd
    B.5.2Functional name of contact pointAllergan Ltd, EU Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressMarlow International, Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4401628494444
    B.5.5Fax number+4401628494449
    B.5.6E-mailml-eu_reg_affairs@allergan.com
    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 BOTOX®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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®
    D.3.4Pharmaceutical form Powder 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 TOXIN TYPE A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeAGN 191622
    D.3.9.3Other descriptive nameBotox purified neurotoxin complex
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to Allergan Units
    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 Yes
    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 placeboPowder for solution 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
    Treatment of lateral canthal rhytides in the periorbital region (Crow's Feet Lines)
    E.1.1.1Medical condition in easily understood language
    Treatment of facial wrinkles (Crow's Feet Lines)
    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 13.1
    E.1.2Level PT
    E.1.2Classification code 10040954
    E.1.2Term Skin wrinkling
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of BOTOX compared to placebo in subjects with
    lateral canthal rhytides in the periorbital region (Crow's Feet Lines).
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female 18 years of age or older
    2. Presence of bilaterally symmetrical CFL of moderate to severe rating at maximum smile, as measured using the FWS by both the investigator and subject at day 1(prior to study treatment) (investigator and subject rating at maximum smile must be the same)
    3. Subjects must have sufficient visual acuity without the use of eyeglasses (contact lens use acceptable), to accurately assess their facial wrinkles
    4. Female subjects of childbearing potential must have a negative urine pregnancy test at day 1 prior to study treatment. A woman is considered NOT to be of childbearing potential if she either is postmenopausal with at least 12 consecutive months of amenorrhea or has no uterus.
    5. Written informed consent has been obtained
    6. Written Authorization for Use and Release of Health and Research Study Information (US sites only) and Data Protection Consent (European sites only) and/or other documentation in accordance with the relevant country and local privacy requirements has been obtained
    7. Ability to follow study instructions and likely to complete all required visits.
    E.4Principal exclusion criteria
    1. Any condition which precludes a subject’s ability to comply with study requirements, including completion of the study visits or inability to read, understand, and/or self-assess CFL severity using the FWS
    2. Concurrent or previous botulinum toxin treatment of any serotype
    3. Known immunization or hypersensitivity to any botulinum toxin serotype
    4. Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
    5. Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
    6. Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures
    7. Any of the following procedures or treatments occurring in the specified period prior to enrollment (day 1)
    a. 3 months: Non-ablative resurfacing laser or light treatment, microdermabrasion or superficial peels
    b. 6 months: Any facial cosmetic procedure with medium depth to deep facial chemical peels (eg, trichloroacetic acid [TCA] and phenol), or mid facial or periorbital laser skin resurfacing
    c. 12 months: Mid facial or periorbital treatment with non-permanent soft tissue fillers
    8. Subjects on topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain the same regimen for the study
    9. Subjects on oral retinoid therapy within 1 year prior to study enrollment
    10. Prior periorbital surgery, facial lift (full face or mid face), brow lift, or related procedures (eg, eyelid (blepharoplasty) and/or eyebrow surgery)
    11. Prior mid face or periorbital treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation
    12. Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial rhytides even by physically spreading them apart, as determined by the investigator
    13. Presence of any clinically relevant abnormal finding as observed from the neurologic assessment (See Protocol)
    14. Any eyebrow or eyelid ptosis at baseline as determined by the investigator
    15. Infection or skin disorder at the injection sites
    16. History of facial nerve palsy
    17. Females who are pregnant, nursing, or planning a pregnancy
    18. Females of childbearing potential, not using a reliable means of contraception
    19. Any uncontrolled systemic disease
    20. Recent history of alcohol or drug abuse based on the investigator’s judgment
    21. Anticipated need for surgery or overnight hospitalization during the study
    22. Subjects who plan for an extended absence away from the immediate area of the study center that would preclude them from returning for all protocol specified study visits
    23. Subjects who, in the investigator’s opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period
    24. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
    25. Permanent make-up which would interfere with the assessment of facial wrinkles
    26. Subject has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy endpoints are the proportion of subjects achieving a grade of none or mild on the investigator’s and on the subject’s assessment of the severity of CFL at maximum smile, based on the FWS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 30 of the first treatment cycle
    E.5.2Secondary end point(s)
    The Secondary efficacy endpoints are:

    1. The proportion of responders of the investigator’s FWS in CFL at rest at day 30, among subjects who were rated as at least mild at baseline, where a responder is defined as achieving a 1-grade improvement on the investigator-rated FWS at rest in CFL.

    2. The proportion of responders of the investigator’s FWS in CFL at maximum smile at day 30, where a responder is defined as achieving a 1-grade improvement on the investigator-rated FWS at maximum smile in CFL.

    3. The proportion of responders of the investigator’s FWS in CFL at maximum smile at day 30, where a responder is defined as achieving a rating of none or mild on the investigator-rated FWS at maximum smile in CFL (for US FDA only).

    4. Values at day 30 for the subject’s Global Assessment of Change in CFL (using a 7-point scale) will be analyzed using analysis of variance (ANOVA) with treatment, as the main effect.

    5. The proportion of subjects with a ≥ 2 point improvement over baseline for FLO item #2 at day 30: When I look in the mirror, my facial lines make me look older than I want to look.

    6. The proportion of subjects with a ≥ 2 point improvement over baseline for FLO item #5 at day 30: My facial lines make me look less attractive.

    7. The proportion of subjects with a ≥ 3 point improvement over baseline for FLO item #8 at day 30: My facial lines make me look tired.

    8. Analysis will be performed on the proportion of subjects at day 30, who rate themselves in a younger SPA category than at baseline (ie, from “look my current age” at baseline to “look younger” or from “look older” at baseline to “look my current age/younger”). Only subjects who rated themselves as looking their current age or older at baseline will be included in the denominator of this analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Day 30.
    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 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 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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Canada
    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
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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: 223
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 222
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 445
    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)
    Patients will return to previous treatment options
    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 Decision2010-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-16
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