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    The EU Clinical Trials Register currently displays   38002   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-002410-35
    Sponsor's Protocol Code Number:10 0330 02 - 0486
    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:2007-02-01
    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 number2006-002410-35
    A.3Full title of the trial
    Double-blind, double-dummy, randomized, placebo-controlled, five-armed, multi-centre phase II/III study to evaluate the efficacy and safety of different concentrations of isotretinoin versus doxycycline in the treatment of rosacea, subtype II and III
    A.3.2Name or abbreviated title of the trial where available
    AURORA
    A.4.1Sponsor's protocol code number10 0330 02 - 0486
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 Yes
    D.2.1.1.1Trade name Aknenormin 10 mg Weichkapseln
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall Hermal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameIsotretinoin
    D.3.2Product code 10033002
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsotretinoin
    D.3.9.1CAS number 4759-48-2
    D.3.9.2Current sponsor code10033002
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.2.1.1.1Trade name Doxyderma 50
    D.2.1.1.2Name of the Marketing Authorisation holderDermapharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDoxycyclin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDoxycyclin
    D.3.9.1CAS number 564-25-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients aded 18 and older suffering from papulopustular rosacea (subtype II) or moderate phymateous rosacea (moderate subtype III) with a minimum grade 4 in the 'Global physicians's assessment score - Rosacea' (= Half of the face centrofacial and frontal covered with small papules. Some pustules or prominent papules/noduli, edema and strong erythema, telangiectasia) and a minimum of 8 inflammatory lesions.
    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
    The aim of the study is to show that at least one of the three different chosen concentrations of isotretinoin is non-inferior to doxycycline and superior to placebo.

    As primary objective the reduction in the total sum of facial papules and pustules/nodudi after a 12 week treatment will be compared between the treatment groups.
    E.2.2Secondary objectives of the trial
    As secondary objectives the following efficacy variables will be compared between the treatment groups:
    - changes in the static “Global physician’s assessment score – Rosacea”
    - changes in the severity scores for erythema, edema, telangiectasia, seborrhoea, and rhinophyma
    - investigator’s overall improvement rating
    - patient’s overall improvement rating
    - changes in the quality of life measured by patient reported outcomes
    - achievement of patient’s treatment preferences

    As secondary objectives the following safety variables will be compared between the treatment groups:
    - changes in laboratory values
    - overall tolerability based on number and severity of study medication-related AEs/SAEs
    As a further secondary objectives the following safety variables will be compared between the isotretinoin treatment groups:
    - changes in the severity scores for mucocutaneous side effects (xerosis cutis, burning and itching, cheilitis, and eye dryness)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · the written informed consent form has been signed and dated
    · papulopustular rosacea (rosacea subtype II) or moderate phymatous rosacea (moderate rosacea subtype III)
    · a minimum grade 4 in the “Global physician’s assessment score – Rosacea”
    · at least 8 inflammatory lesions
    · existence of rosacea for at least three months prior to inclusion
    · age 18 years or older
    · body weight between 50 kg and 130 kg
    · high probability of a good compliance and orderly completion of the study
    FOR FERTILE WOMEN ONLY
    · medically controlled, negative pregnancy test within the first 3 days of the actual menstrual cycle in all women except those who were surgically sterile or at least one year postmenopausal.
    E.4Principal exclusion criteria
    · advanced phymatous rosacea, where phyma in particular rhinophyma is indicated for surgical therapy at the discretion of the investigator
    · exclusively ocular rosacea
    · nodular rosacea
    · erythematotelangiectatic rosacea
    · severe facial skin dryness or xerosis
    · known keratoconjunctivitis sicca
    · known Sjögren’s syndrome
    · the topical use of any medication that may influence rosacea (e.g. metronidazole, azelaic acid, adapalene or antibiotics) within the last 2 weeks proir to treatment start
    · the systemic use of metronidazole within the last 6 weeks prior to study start
    · systemic antibiotic treatment within the last 6 weeks prior to treatment start – particularly tetracycline
    · need for concomitant antibiotic treatment (except study indication)
    · corticoid treatment within the last month prior to treatment start (exception: inhalation with corticosteroids in subjects with asthma will be allowed at a dose not exceeding 1 mg/day; the dosage should remain consistent throughout the entire study period)
    · need for corticoid treatment (exception: see above)
    · isotretinoin treatment within the last 6 months prior to treatment start
    · use of drugs that can increase sensitivity towards light, e.g. Saint-John’s-wort (hypericum preparations)
    · use of drugs or food supplements containing Vitamin A or ß-carotin
    · known or suspected depression or psychosis, either present or in medical history
    · known or suspected mental or neurological disorders (e.g. dementia, Alzheimer’s disease, Parkinson’s disease)
    · history of malignoma
    · known or suspected gastric or intestine ulcera
    · known or suspected pancreatitis
    · known or suspected oesophagitis
    · known or suspected HIV
    · known or suspected hypervitaminosis A
    · acute nausea and/or diarrhoea
    · liver enzymes (AST, ALT, and γ-GT) higher than 2 fold upper limits of normal (ULN)*
    · triglycerides higher than 1.5 fold upper limits of normal (ULN)*
    · cholesterol higher than 1.5 fold upper limits of normal (ULN)*
    · pregnant or breast-feeding women
    · participation in another clinical trial within 30 days directly preceding the administration of the study drug
    · simultaneous participation in another clinical trial
    · any suspicion of drug and/or alcohol abuse
    · clinical history suggestive of intolerance or allergy to one of the products
    · any chronic disease that may affect the absorption, metabolism or elimination of the investigational product
    * = based on screening blood sampling

    FOR FERTILE WOMEN ONLY
    · fertile women without hormonal contraception during the last menstrual cycle prior to study start and/or not willing to accept the continuation of this hormonal contraception (combination oral contraceptive, hormonal patch, hormonal implants, hormonal injections, IUD – hormonal intra uterine device) during the entire study and for at least 35 days after end of treatment
    · fertile women not willing to accept two established and reliable methods of contraception including one barrier method during the entire study and for at least 35 days after end of treatment
    E.5 End points
    E.5.1Primary end point(s)
    The reduction in the total sum of facial papules and pustules/noduli is the primary efficacy variable. The reduction will be measured as difference in the total sum from baseline to end of treatment after 12 weeks.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) 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) Yes
    E.8.2.2Placebo Yes
    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 concerned25
    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 years
    E.8.9.1In the Member State concerned months17
    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 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 Information not present in EudraCT
    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 state550
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 550
    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 patients will be asked to participate voluntarily in a post-study observation in order to obtail information about remission periods. This post-study observation will be described in a separate obsevation plan.
    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 Decision2006-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-31
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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