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    Summary
    EudraCT Number:2016-003501-33
    Sponsor's Protocol Code Number:DECOLAD
    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:2016-10-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-003501-33
    A.3Full title of the trial
    A prospective, single center, randomized, double-blind, placebo controlled study in two phases to evaluate the safety and efficacy of ATx201 as a topical antibiotic agent
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A single center randomised placebo controlled study to test a novel topical formulation containing Niclosamide, an antibiotic.
    A.3.2Name or abbreviated title of the trial where available
    DECOLAD
    A.4.1Sponsor's protocol code numberDECOLAD
    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 SponsorAntibioTx ApS
    B.1.3.4CountryDenmark
    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 supportAntibioTx ApS
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntibioTx ApS
    B.5.2Functional name of contact pointAntibioTx ApS
    B.5.3 Address:
    B.5.3.1Street AddressKemitorvet 220
    B.5.3.2Town/ cityLyngby
    B.5.3.3Post codeDK-2800
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4540103044
    B.5.6E-mailrasmus.toft-kehler@antibiotx.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 No
    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 nameATx201
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNiclosamide, anhydrous
    D.3.9.1CAS number 50-65-7
    D.3.9.2Current sponsor codeATx201
    D.3.9.3Other descriptive nameNICLOSAMIDE
    D.3.9.4EV Substance CodeSUB09230MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    AntibioTx has developed a topical product (ATx201) for treatment of infected eczema and infected atopic dermatitis. These infections are predominantly caused by Staphyllococcus aureus and various species of Streptococcus. Treatment of these infections is plagued by inactivity of or resistance towards the main topical antibiotics (fucidic acid, mupirocin and retapamulin).
    E.1.1.1Medical condition in easily understood language
    To treat skin infections with bacteria. AntibioTx develops topical formulations containing an Antibiotic substance.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10040788
    E.1.2Term Skin and subcutaneous tissue bacterial infections
    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
    The primary objective of the study is to demonstrate the safety and tolerability of new topical formulations of ATx201 in healthy volunteers, and in a population of patients with atopic dermatitis and to assess efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4 and 7 days of treatment. Therefore, in Phase I of the study, three formulations of ATx201 including the respective Placebos will be applied to healthy volunteers. One formulation will advance into Phase II, where patients will be treated with the respective formulation or Placebo.
    E.2.2Secondary objectives of the trial
    Phase I:
    - To determine the local and systemic exposure of ATx201
    - Exploratory Objective:
    To collect illustrative information on local tolerability of ATx201
    To determine the best tolerable formulation to advance into Phase II.
    Phase II:
    - To assess the impact of ATx201 on the treated atopic dermatitis lesion
    - To determine the systemic exposure of ATx201
    - Exploratory Objectives:
    To assess the impact of ATx201 and formulation on pruritus (using a VAS scale)
    To collect illustrative information on efficacy of ATx201
    To assess the EASI score per single lesion
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General inclusion criteria:
    - Signed and dated informed consent has been obtained
    - Age 18 – 70 years
    - Male or female
    - Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior trial treatment
    - Female subjects of childbearing potential must be willing to use effective contraceptive at trial entry until completion
    - Male subjects must agree to use adequate contraception for the duration of the trial

    Additional inclusion criteria for Phase II of the study:
    - Localized disease where two individual lesions each covering an area between 10-200 cm2 and where each individual lesion has an investigator global assessment (IGA) score between 1-4 and is colonized by S. aureus with at least 1,000 cfu/cm2.
    - Additional localized lesion of area between 10-200 cm2 and where the individual lesion has an investigators global assessment (IGA) score between 1-4.
    E.4Principal exclusion criteria
    General exclusion criteria
    - Clinically relevant abnormalities in the laboratory testing, vital signs, ECG (Phase I only) or physical examination unless considered clinically irrelevant for the scope of the trial by the Investigator
    - Presence of any skin condition (scars, tattoos,…) that would interfere with the placement of study medication
    - History of irritation to topical products
    - Current acute or chronic disease unless considered clinically irrelevant for the scope of the trial by the Investigator
    - Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
    - Positive HIV serology or evidence of active hepatitis
    - Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drugs (test, reference)
    - History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
    - Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal
    - Subject considered unable or unlikely (per Investigator judgment) to comply with safety and PK profiling requirements (follow-up visits)
    - Subjects who are pregnant (as determined by a positive pregnancy test at the screening visit) or lactating
    - Participation in another clinical trial with an investigational drug within 4 weeks before Screening

    Additional exclusion criteria for Phase I of the study:
    - Regular use of medications unless considered clinically irrelevant by the Investigator
    - Use of any dermatological drug therapy on the arms within 14 days before day 1 of this study

    Additional exclusion criteria for Phase II of the study:
    - Treatment with antibiotics (systemic or topical) within the past 2 months taken for systemic application, and four weeks use of topical antibiotics prior entering the study, and use of those during the study
    - Treatment with cyclosporins within the last four weeks, use of methotrexate or mycophenolate mofetil within the last eight weeks, and biologicals within 5 times the biological half life prior to entering the study.
    - Treatment with topical (dermatological) steroids and calcineurin inhibitors 1 week prior to start of treatment and during the study
    - Treatment with systemic steroids within the past month and during the study
    - Use of disinfectant soaps within 1 week before screening and during the study treatment period
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint is the treatment success, defined as a 100-fold reduction in the S. aureus colony count/cm2 of sampled skin lesion after 4 and 7 days treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 4 and 7 days of treatment.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoint is the relative decrease of S. aureus colonies/cm2 on treated skin after 4 and 7 days treatment of the active groups, relative to their Placebos as well as relative to the non treated area.

    All safety endpoints (including physical exam, vital signs, ECG (phase I only), safety laboratory)
    Number and type of (serious) adverse events
    Local tolerability assessment scores compared to Placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: After 4 and 7 days of treatment
    Safety: Screening until End of study
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    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 months9
    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: 66
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state76
    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)
    Healthy voluhnteers: no post treatment planned
    Patients: standard of care treatment
    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 Decision2016-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-12
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