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    Summary
    EudraCT Number:2014-002068-34
    Sponsor's Protocol Code Number:2013-RC-09
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-002068-34
    A.3Full title of the trial
    Prospective Multicentric Open Randomised Controlled Trial comparing Topical Aluminium Chloride to Onabotulinumtoxin A Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
    Etude prospective multicentrique ouverte, contrôlée, randomisée comparant les traitements par sels d’aluminium topiques et par toxine botulique type A en injections intradermiques dans l’hyperhidrose des membres résiduels (membres inférieurs)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Residual Limb Hyperhidrosis Treatment : Aluminium Chloride versus Onabotulinumtoxin A
    Traitement de l’hyperhidrose des membres résiduels :
    sels d’aluminium versus toxine botulique
    A.3.2Name or abbreviated title of the trial where available
    SALUTOX
    A.4.1Sponsor's protocol code number2013-RC-09
    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 SponsorDIRECTION CENTRALE DU SERVICE DE SANTE DES ARMEES
    B.1.3.4CountryFrance
    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 supportDIRECTION CENTRALE DU SERVICE DE SANTE DES ARMEES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDIRECTION CENTRALE DU SERVICE DE SANTE DES ARMEES
    B.5.2Functional name of contact pointMedecin en chef Le Bevic
    B.5.3 Address:
    B.5.3.1Street AddressFort Neuf De Vincennes Cours des Maréchaux
    B.5.3.2Town/ cityPARIS CEDEX 12
    B.5.3.3Post code75614
    B.5.3.4CountryFrance
    B.5.4Telephone number00331 41 93 26 88
    B.5.5Fax number00331 41 93 27 36
    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, 100 units
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.11 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous liquid
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Residual Limb Hyperhidrosis is the investigated medical condition.
    E.1.1.1Medical condition in easily understood language
    Amputees often suffer from hyperhidrosis (important production of sweat), which is responsible for prosthesis function impairments, dermatological problems and quality of life impairments.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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 demonstrate Onabotulinumtoxin A superiority to aluminium chloride for the treatment of residual limb hyperhidrosis
    Objectif principal : montrer la supériorité du traitement par OnabotulinumtoxinA à celui par sels d'aluminium dans le traitement de l’hyperhidrose des membres résiduels.
    E.2.2Secondary objectives of the trial
    To compare quality of life improvement
    To compare functional improvement
    To observe treatment impact on pain
    To compare treatment tolerance
    Objectifs secondaires : comparer la tolérance et l’impact sur la qualité de vie du traitement de l'hyperhidrose des membres résiduels par OnabotulinumtoxinA à ceux du traitement par sels d'aluminium ; Observer l’impact des deux traitements sur les douleurs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Lower limb amputees suffering from residual limb hyperhydrosis with important cutaneous, functional, social and professional consequences, whatever the amputation cause.
    • HDSS ≥ 2 (Hyperhidrosis Disease Severity Score)
    • Men and women
    • 18 to 75 years old
    • Written informed consent
    • No exclusion criteria
    • Social assurance
    • Patients amputés du ou des membres inférieurs, présentant une hyperhidrose du ou des membres résiduels avec des conséquences cutanées, fonctionnelles ou socioprofessionnelles importantes, quelle que soit la cause de l’amputation
    • HDSS ≥ 2
    • Sexe : homme ou femme
    • Age : 18 à 75 ans
    • Consentement écrit du patient
    • Absence de critère d’exclusion
    • Assuré social
    E.4Principal exclusion criteria
    • Botulinum toxin injection necessity for another disease
    • Evolutive Central neurologic disease or myasthenia.
    • Egg or albumine allergy
    • Botulinum toxin or other excipients hypersensibility
    • Legally protected Adults and people unable to give an informed consent. (article L-1121-8 from Public Health Code), people without freedom and people hospitalized without consent (article L-1121-6 from Public Health Code)
    • Pregnant women or giving breast women (article L-1121-5 from Public Health)
    • Patient refusing participating
    • Previous hyperhidrosis treatment with aluminium chloride in the last 4 weeks
    • Previous hyperhidrosis treatment with boutlinum toxin in the last 2 years
    • Other ongoing hyperhidrosis treatment
    • Large residual limb eczematiform lesions: corticoïde treatment (for example : Locapred® 1 application per day during 1 week then decrease).
    • Aminoglycoside ongoing treatment
    • Précédent traitement de l’hyperhidrose par sels d’aluminium depuis moins de 4 semaines.
    • Précédent traitement de l’hyperhidrose par toxine botulique depuis moins de 2 ans.
    • Autre traitement de l’hyperhidrose en cours
    • Lésions cutanées eczématiformes étendues sur le membre résiduel : traitement par corticoïdes (exemple : Locapred® 1 application le soir pendant 1 semaine puis décroissance).
    • Prise d’aminosides
    • Injection de toxine botulique pour une autre indication
    • Poussée évolutive d’une maladie neurologique centrale ou de myasthénie
    • Allergie à l’œuf ou à l’albumine
    • Hypersensibilité à la toxine botulique ou aux autres excipients.
    • Majeurs sous régime de protection légale ou hors d’état d’exprimer leur consentement (article L-1121-8 du Code de Santé Publique), personnes privées de liberté ou hospitalisées sans consentement (article L-1121-6 du Code de Santé Publique)
    • Femmes enceintes ou allaitantes (article L-1121-5 du Code de Santé Publique)
    • Refus du patient de participer à l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    decrease of HDSS:
    - efficacy : from 2 to 1, from 3 to 1 or 2, from 4 to 1 or 2
    - failure : from 2 to 2, from 3 or 4 to 2; or increase of HDSS

    INITIAL HDSS FINAL HDSS CONCLUSION
    2 2 failure
    2 1 efficacy
    3 ou 4 3 ou 4 failure
    3 ou 4 1 ou 2 efficacy
    • Baisse de l’HDSS
    o Efficacité : de 1 si initialement à 2, de 1 ou 2 si initialement à 3, et de 2 si initialement à 4.
    o Echec : reste à 2 si initialement à 2, reste >2 si initialement à 3 ou 4, ou augmente.

    HDSS INITIAL HDSS FINAL CONCLUSION
    2 2 inefficace
    2 1 efficace
    3 ou 4 3 ou 4 inefficace
    3 ou 4 1 ou 2 efficace
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0
    Week 4
    Week 12
    Week 18
    Week 24
    J0
    S4
    S12
    S18
    S24
    E.5.2Secondary end point(s)
    • Amount of time spent wearing the prosthesis (hours per day): efficacy if increase
    • Number of times the prosthesis had to be removed to dry the residual limb and sleeve per day: efficacy if no need to remove it or only once a day
    • Visual Analogue Scale (VAS) for mismatch of prosthesis associated with sweat (using 100 mm scale): efficacy if>50% increase
    • VAS for problems with walking due to sweat (using 100 mm scale): efficacy if>50% increase
    • VAS for overall discomfort associated with sweat (using 100 mm scale) : efficacy if>50% increase
    • VAS sweat quantity (using 100 mm scale) : efficacy if>50% increase
    • VAS quality of life (using 100 mm scale) : efficacy if increase
    • DLQI quality of life questionnaire : efficacy if increase
    • SF36 "limitations due to physical state" specific domain : efficacy if increase
    • Subjective Improvement Felt (SIF) (based on a percentage scale) : efficacy if>50% increase
    • VAS for sweat quantity (using 100 mm scale) : efficacy if>50% increase
    • Pain in the residual limb, phantom limb and neuroma : observation
    • Description of skin damage : efficacy if disappear
    - Qualification des effets secondaires de chacun des traitements : observation
    - ASR : efficacité si amélioration ≥ 50%
    - EVA gêne globale liée à la sueur : efficacité si amélioration ≥ 50%
    - EVA désadaptation de prothèse liée à la sueur : efficacité si amélioration ≥ 50%
    - EVA troubles de la marche liés à la sueur : efficacité si amélioration ≥ 50%
    - Temps de port de prothèse en h/j : efficacité si augmentation
    - Nb de déchaussage de prothèse par jour pour sécher : efficacité si disparition ou diminution à 1 déchaussage par jour
    - EVA quantité de sueur : efficacité si amélioration ≥ 50%
    - EVA Qualité de vie, score DLQI, score du domaine spécifique de la SF36 « limitations dues à l’état physique » : efficacité si amélioration
    - Lésions cutanées : efficacité si disparition
    - Douleurs de membre résiduel, de membre fantôme et de névrome : observation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0
    Week 4
    Week 12
    Week 18
    Week 24
    J0
    S4
    S12
    S18
    S24
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    sels d'aluminium topiques, ETIAXIL, produit cosmétique
    topical Aluminium chloride, ETIAXIL, cosmetic product
    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 concerned6
    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 years
    E.8.9.1In the Member State concerned months30
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state54
    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 Decision2015-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-21
    P. End of Trial
    P.End of Trial StatusOngoing
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