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    Summary
    EudraCT Number:2008-005075-10
    Sponsor's Protocol Code Number:CL08002
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-05
    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 ConcernedFinland - Fimea
    A.2EudraCT number2008-005075-10
    A.3Full title of the trial
    Double-blind, vehicle-controlled, two-phase, single centre Phase I/IIa study with topical twice daily doses of 5% cis-urocanic acid to investigate pharmacokinetics, safety, tolerability and efficacy for up to 28 days in subjects with mild to moderate atopic dermatitis
    A.4.1Sponsor's protocol code numberCL08002
    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 SponsorBioCis Pharma Oy
    B.1.3.4CountryFinland
    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.3.1Product nameCis-urocanic acid 5 % emulsion cream
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7699-35-6
    D.3.9.2Current sponsor codeCis-UCA
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCream
    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
    Chronic mild to moderate atopic dermatitis
    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 evaluate pharmacokinetics of cis-UCA after topical twice daily doses for 10 days in adult subjects with mild to moderate atopic dermatitis
    E.2.2Secondary objectives of the trial
    - To evaluate safety and tolerability of cis-UCA after topical twice daily doses for up to 28 days in adult subjects with mild to moderate atopic dermatitis
    - To obtain preliminary information on the efficacy of cis-UCA after topical twice daily doses for up to 28 days in adult subjects with mild to moderate atopic dermatitis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent obtained prior to any screening procedures
    2. White skinned male or female subjects
    3. Age between 18-65 years of age
    4. Subjects with chronic mild to moderate atopic dermatitis with the following diagnostic features:
    - History within 12 months of itching dermatitis in one or several of localizations typical of atopic dermatitis (antecubital/cubital fossae; face/neck/upper trunk; volar aspects upper extremities / thighs).
    - Objective signs of mild or moderate eczema OR dry skin in one or several of above mentioned locations
    5. No current treatment with active medication for atopic dermatitis
    6. Symmetric presentation of atopic dermatitis in the volar forearms to allow randomization of the treatments
    7. Good general health ascertained by medical history, physical examination, ECG-recording and laboratory determinations, showing no signs of clinically significant findings, except chronic atopic dermatitis
    8. Negative pregnancy test (premenopausal female subjects) at screening and use of adequate contraceptive measures (both male and female subjects) throughout the study and 30 days after the last cis-UCA dose
    - Premenopausal female volunteers should be either surgically sterile or using a reliable contraception method: intrauterine device (hormonal or non-hormonal); oral combination pill or hormonal contraception patch; or two of the following: intra-vaginal hormonal ring, oral contraceptive containing progestin only, spermicidal foam, condom, sterilization of male sexual partner (surgical vasectomy)
    - Subjects with no current heterosexual relationship may be included according to the judgment of the Investigator
    - If menopause occurred 2 years ago at the minimum, no contraception is required for female participants, nor pregnancy tests
    - Reliable contraception for male subjects is concordant with above listed methods for females, as applicable
    9. Body weight 60-100 kg for males and 45 -85 kg for females; body mass index (BMI) 18-30 kg/m2
    10. Supine blood pressure (BP) after 3 minutes rest: systolic 100-150 mmHg, diastolic 60-90 mmHg, and supine heart rate (HR) after at least 3 minutes rest: 40-90 beats per minute
    11. Non-smoker and not using any nicotine products
    E.4Principal exclusion criteria
    1. History of other significant skin disease (e.g. any skin disease requiring hospitalization), or skin manifestations of allergic illness or other dermatologic condition, except chronic mild to moderate atopic dermatitis, that would interfere with the trial assessments or compromise the subject’s safety according to the opinion of the Investigator
    2. Present symptoms of other skin diseases, except chronic atopic dermatitis, that could disturb the study assessment and evaluation of the skin, according to the opinion of the Investigator
    3. Current use of any active systemic medication (i.e. oral, subcutaneous, intravenous) for chronic atopic dermatis within one month (30 days)
    4. Current use of active topical medication in the investigational area for chronic atopic dermatis within one month (30 days)
    5. History of a sunny holiday or solarium use within one month (30 days) before beginning of study treatments, or planning such during the study or within 30 days after the study
    6. Asymmetric presentation or only single lesion of atopic dermatitis on volar forearms
    7. Tattoos on the volar side of either forearm
    8. Damaged skin at the test site (e.g. uneven skin pigmentation, numerous freckles, scars or other disfigurations) or clinical signs or symptoms of skin irritation (e.g. pruritus, burning, erythema)
    9. Allergy to cis-UCA, or any constituents of Aqualan® (decyl oleate, cetearyl alcohol, glycerine, sodium cetearyl sulphate and methylparaben)
    10. History of any cancer or current cancer
    11. Earlier participation in a clinical study performed with cis-UCA
    12. Use of prescription drugs within 14 days prior to dosing or over the counter medication within 7 days prior to dosing. Paracetamol is allowed for occasional pain. Antihistamine is allowed for allergic symptoms. Non-cortisone nasal sprays and eye drops are also allowed.
    13. Donation of blood or participation in another drug study within 60 days (males) or 90 days (females) before the first product administration in this study
    14. Any medical condition (such as renal impairment) which might significantly alter the absorption, distribution or excretion of cis-UCA
    15. Any clinically significant laboratory test result (including positive tests for HIV and hepatitis B or C)
    16. Excessive use of alcohol (on average more than 24 units per week for males, and more that 16 units per weeks for females; unit = 4 cl spirits or equivalent)
    17. Suspected current use of illicit drugs (medical history, physical examination, screening laboratory determinations)
    18. Clinically significant illness during the 4 weeks prior to the first dose administration (as determined by the Investigator)
    19. Any other condition that in the opinion of the Investigator would interfere with the evaluation of the study results or constitute a health hazard for the subject
    20. Unwillingness or doubtful capacity to comply with the protocol
    21. Doubtful availability, in the opinion of the Investigator, to complete the study
    22. Poor peripheral venous access
    E.5 End points
    E.5.1Primary end point(s)
    The pharmacokinetic parameters will be determined from the concentration-time data of plasma and urine cis-urocanic acid.
    The safety and tolerability of cis-urocanic acid after repeated topical doses up to 28 days will be evaluated by collecting adverse events and assessing visual skin reaction severity scoring for erythema, skin swelling, formation of papules, formation of vesicles or bullaes, and scaling.
    The efficacy of cis-urocanic acid on mild to moderate atopic dermatitis will be assessed by evaluating skin erythema, transepidermal water loss, Physician's Global Assessment (PGA), and the total body Ezcema Area Severity Index (EASI).
    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 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 No
    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.8.3 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 Information not present in EudraCT
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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) 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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-08-05. Yes
    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 state18
    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 Decision2008-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
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