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    Summary
    EudraCT Number:2021-000877-10
    Sponsor's Protocol Code Number:MWTBTXA
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-19
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-000877-10
    A.3Full title of the trial
    Longevity of microwave thermolysis and botulinum toxin A for treatment of axillary hyperhidrosis:
    a randomized intra-individual trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of microwaves thermolysis and botulinum toxin A for treatment of increased sweat from armpits
    Sammenligning af mikrobølge-termolyse og botulinum toxin A til behandling af øget armhulesved
    A.4.1Sponsor's protocol code numberMWTBTXA
    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 SponsorBispebjerg Hospital, Department of Dermatology
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMiraDry, Sientra
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBispebjerg Hospital, Department of Dermatology
    B.5.2Functional name of contact pointGabriela Lladó Grove
    B.5.3 Address:
    B.5.3.1Street AddressNielsine Nielsens Vej 9
    B.5.3.2Town/ cityKoebenhavn NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.6E-mailggro0013@regionh.dk
    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 BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum Toxin A
    D.3.9.1CAS number 93384-43-1
    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/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16,66
    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
    Axillary hyperhidrosis
    E.1.1.1Medical condition in easily understood language
    Excessive armpit sweat
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10020642
    E.1.2Term Hyperhidrosis
    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
    The study aim is to assess and compare treatment effect of MWT and BTX-A for axillary hyperhidrosis with focus on longevity. We also aim to assess patient satisfaction, local skin responses and adverse reactions in relation to treatment.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudy, V1, 16.02.21
    Optionally, up to 12 patients will be included in a sub-study investigating the axillary tissue characteristics with histological assessment with punch biopsies, and supplemented by OCT-imaging, both at baseline and after treatment with MWT and BTX-A.
    E.3Principal inclusion criteria
    Eligible patients for this study must meet the following criteria:
    1) Subject has provided written informed consent
    2) Subject is 18 years of age or older
    3) A unilateral HDSS score of 3 or 4 for each axilla
    4) A gravimetric measurement of at least 50 mg/5 min for women and 100 mg/5 min for men in at least one axilla. The contralateral axilla should not be below 40 mg (women) and 80 mg (men).
    5) Women of childbearing potential must be confirmed not pregnant by a negative u-HCG prior to study treatment and must use a safe contraceptive method at baseline.
    E.4Principal exclusion criteria
    Candidates will be excluded if the following conditions apply:
    1) Patients with generalized hyperhidrosis
    2) Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs)
    3) Daily use of systemic or topical antibiotics and/or steroids in axillae at the time of inclusion
    4) Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days)
    5) Abnormal skin (e.g. rash, infection, dermatitis) in the axilla at the time of inclusion
    6) Breast tissue in the axillae
    7) Treatment with Isotretinoin within the past 6 months
    8) Axillary laser or IPL treatment within the past 6 months
    9) Botulinum toxin-injections in the axillae within the past 12 months prior to baseline
    10) Known allergies to botulinum toxin, iodine, lidocaine or adrenaline
    11) Prior axillary surgery
    12) Limited motion in the shoulder joint or neurologic deficit in upper limb
    13) History of diseases resulting in muscle weakness (ALS, Lou Gehrig’s), dysphagia (Myasthenia Gravis or Lambert Eaton Syndrome) or respiratory compromise
    14) Axillary lymph node enlargement or -removal or lymphedema in either upper limb
    15) History of hidradenitis suppurativa or history of reoccurring infections/abscesses
    16) History of breast cancer
    17) Electronic device implant
    18) If female; lactating, pregnant or planning on becoming pregnant during the study
    E.5 End points
    E.5.1Primary end point(s)
    Axillary sweat reduction following treatment with MWT and BTX-A at 6 months follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline compared to 6 months follow-up
    E.5.2Secondary end point(s)
    o Patient satisfaction of BTX-A and MWT treatments for axillary hyperhidrosis at 6 and 12 months follow-up
    o Axillary sweat reduction following treatment with MWT and BTX-A at 1, 3, 9 and 12 months
    o Quality of life at 1, 3, 6, 9 and 12 months following treatment with MWT and BTX-A
    o Axillary odor reduction 1, 3, 6, 9 and 12 months following treatment with MWT and BTX-A
    o Axillary hair reduction at 6 months compared to baseline evaluated with clinical photos
    o Visual axillary sweat at 1, 3, 6, 9, 12 months compared to baseline
    o Procedure-related discomfort during treatment with MWT and BTX-A
    o Local skin response and treatment-related adverse effects during and following treatment with MWT and BTX-A
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 2 days FU (tel.), 1-, 3-, 6-, 9- and 12-months follow-up
    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) 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-individual comparison of treatments with a split-patient design
    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
    Medical device
    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
    Patients may be terminated or withdrawn from the study before time for the following reasons:
    o Withdraws consent – meaning that patient chooses not to further participate in the study
    o Change in health status and/or medications that in the physician’s opinion would conflict with the study
    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: 30
    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 No
    F.3.2Patients Yes
    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 state30
    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)
    After study completion, the patients will be offered a second treatment with the procedure they prefer if persistent sweat reduction is not obtained in both axillae. Hence, if a lasting sweat reduction is obtained in one axilla, the patient will be offered the same treatment for the contralateral axilla.
    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 Decision2021-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-24
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