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    Summary
    EudraCT Number:2009-011931-11
    Sponsor's Protocol Code Number:H 552 000 - 0911
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-011931-11
    A.3Full title of the trial
    Explorative, double-blind, randomized, controlled multi-center phase II study to evaluate the efficacy and safety of topically applied combinational product LAS41003 once daily versus corresponding mono-preparations in the treatment of superficial infected eczema
    A.3.2Name or abbreviated title of the trial where available
    LA 41003
    A.4.1Sponsor's protocol code numberH 552 000 - 0911
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlmirall Hermal GmbH
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code LAS41003
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    Local use (Noncurrent)
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTENIDINE
    D.3.9.1CAS number 71251020
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNICARBATE
    D.3.9.1CAS number 73771047
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    Local use (Noncurrent)
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNICARBATE
    D.3.9.1CAS number 73771047
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 3
    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 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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    Local use (Noncurrent)
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTENIDINE
    D.3.9.1CAS number 71251020
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Patients aged 18 and older suffering from at least one clinically diagnosed superinfected or impetiginised eczema such as e.g.
    • superinfected or impetiginised atopic eczema
    • superinfected or impetiginised allergic contact eczema
    • superinfected or impetiginised toxic contact eczema
    • (nummular) microbial eczema
    • superinfected or impetiginised eczema of unknown origin.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10021773
    E.1.2Term Infected eczema
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10014184
    E.1.2Term Eczema
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10014188
    E.1.2Term Eczema allergic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10014191
    E.1.2Term Eczema atopic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10014199
    E.1.2Term Eczema infected
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10014201
    E.1.2Term Eczema nummular
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10051890
    E.1.2Term Eczema impetiginous
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10000618
    E.1.2Term Actinic reticuloid-photosensitive eczema
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10001712
    E.1.2Term Allergic eczema
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10003641
    E.1.2Term Atopic eczema
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10010803
    E.1.2Term Contact eczema
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10014206
    E.1.2Term Eczematous dermatitis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10021773
    E.1.2Term Infected eczema
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10049706
    E.1.2Term Eczematous dermatitis infected
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to determine the efficacy and safety of a once daily topical application of the combinational cream (Octenidine (0.25%) + Prednicarbate (0.25%)) compared to a once daily application of Octenidine (0.25%), respectively to a once daily application of Prednicarbate (0.25%) cream mono-preparation in the treatment of super- infected or impetiginized eczema.
    The primary study objective is to compare the efficacy, regarding the rate of therapeutic success (defined as the combination of clinical and microbial success) at EOT (V5, day 14), as primary efficacy variable.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare the safety and to evaluate the patient’s compliance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Signed and dated written informed consent
    2. Caucasian male and female patients
    3. Aged ≥ 18 years
    4. Have at least one clinically diagnosed superficial infected eczema confirmed by the following symptoms:
    • exudation/crusting
    • oozing
    • erythema
    • edema
    The cumulative score for these symptoms is at least grade 6 (according to a 4-point severity score used for grading each of the symptoms; Intensities: None = 0, Mild = 1, Moderate = 2, Severe = 3).
    5. The minimal area of the target eczema (selected for complete efficacy evaluation) is not less than 2 cm2
    6. Physical ability to apply the study preparations correctly and to follow the study restrictions and visits
    7. Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception.
    E.4Principal exclusion criteria
    1. Known hypersensitivity, intolerance or allergies against Octenidine, Prednicarbate or other ingredients of the investigational medicinal products (e.g. cetearyl alcohol etc.)
    2. Patients who have general signs of systemic infections like fever, malaise, lymphagitis or swollen lymph nodes and/or need systemic antibiotic treatment
    3. Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication
    4. Have evidence of clinically significant or unstable medical conditions such as:
    • metastatic tumor or tumor with high probability of metastatic spread
    • immunosuppressive disorder (e.g. HIV)
    • hematologic, hepatic, renal, neurologic or endocrine disorder
    • insulin-dependent diabetes mellitus and/or hypoglycaemia if unstable or clinically manifested even under treatment
    5. Diagnose of the following disease:
    • Known active tuberculosis or any history of past tuberculosis of skin
    • Suspected or proven parasitic infection of the treatment
    treatment site (e.g. scabies)
    • Psoriasis
    • Suspected or proven viral infection of skin (e.g. Herpes)
    6. Localization of the eczema:
    • palms of the hands
    • sole of a foot
    • face
    7. An area of more than 8 palms (corresponding to a body surface area of about 1200 cm2) is covered with superficial infected eczema
    8. Have received the following topical treatments for any indication in the treatment areas within the designated time period before treatment with investigational medicinal product (IMP):


    Treatment Time Period
    Topical antibiotics 6 weeks
    Topical antimycotics 2 weeks
    Topical steroids 2 weeks
    Topical immunomodulators 2 weeks
    Antiseptic agents 1 week

    9. Have received the following systemic treatments within the designated period before treatment with IMP:

    Treatment Time Period
    Interferon 6 months
    Cytotoxic drugs 6 months
    Immunomodulators or
    immuno-suppressive therapies 3 months
    Drugs known to have
    major organ toxicity 4 weeks

    Antibiotics 4 weeks
    Antimycotics
    Corticosteroids (oral or injectable) 4 weeks
    Inhaled corticosteroids 4 weeks
    (>1200 microg/day for beclomethasone, or >600 microg/day for fluticasone)
    Antihistamines 48 hours

    10. Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP
    11. Any topical treatment with antiseptics agents within one week before treatment with IMP
    12. Patients having any significant physical abnormalities (e.g. tattoos) in the potential treatment area that may cause difficulty with examination or final evaluation
    13. Patients not willing to stop using skin care products (including sunscreens and make-ups) and washing products during the study within the treatment areas
    14. Have any dermatological disease in the treatment areas or surrounding area that may be exacerbated by treatment with topical Prednicarbate or cause difficulty with examination (e.g. Rosacea, virus infections, vaccination) assessed by the investigator
    15. Are known to be pregnant or lactating.
    16. Are currently or within the past 8 weeks participating in another clinical study.
    17. Any suspicion of current drug and/or alcohol abuse as assessed by the investigator.
    18. Patient is institutionalized because of legal or regulatory order.
    19. Employee of the study site or of the Sponsor’s company.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variables:
    • Rate of therapeutic success of the target eczema at EOT visit (V5, day 14). Therapeutic success will be defined as microbial success and clinical success.
    Microbial analysis of microbial samples taken from the target eczema at EOT (V5) compared to those taken at Screening/Baseline (V1) will be used to evaluate the rate of microbial success, given if microorganisms (bacteria and fungi) detected at Screening/Baseline are at least almost cleared and without clinical relevance.
    The clinical status, assessed by the investigator’s visual inspection, will be graded using the Infected Eczema Severity Score (IESS). The 4-point IESS (Intensities: None = 0, Mild = 1, Moderate = 2, Severe = 3), incorporates typical signs and symptoms of superficial infected eczema (exudation/crusting, oozing, erythema, edema/induration, papulo-vesicles, pustules and scaling).
    Clinical success for the target eczema is given, if the cumulative IESS is not greater than grade 5 in maximum and if none of the symptoms evaluated exceeds grade 1 (mild intensity).
    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 No
    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) 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.8.3 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 concerned20
    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 Information not present in EudraCT
    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
    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 months5
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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 Decision2009-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-29
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