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    Summary
    EudraCT Number:2007-004011-54
    Sponsor's Protocol Code Number:VAL-UOP-C201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-11-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-004011-54
    A.3Full title of the trial
    Ensayo en fase IIa, aleatorizado, doble ciego, controlado con placebo y de comparación intra-individual entre los miembros izquierdo-derecho en 25 pacientes con dermatitis atópica moderada, para investigar la eficacia, irritación local, seguridad, tolerabilidad y farmacocinética de la aplicación tópica dos veces al día con crema ImCOOH al 10% durante 14 días y una aplicación adicional en el día 15.

    (Phase IIa, randomized, double-blind, placebo-controlled, intra-individual left-right limb comparison trial in 25 patients with moderate atopic dermatitis to investigate the efficacy, local irritation, safety, tolerability and pharmacokinetics of twice daily topical applications with 10% ImCOOH cream for 14 days with an additional morning application on Day 15.)
    A.4.1Sponsor's protocol code numberVAL-UOP-C201
    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 SponsorValletta Health BV
    B.1.3.4CountryNetherlands
    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 nameImCOOH 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.3.8INN - Proposed INNimidazole-4-carboxylic acid
    D.3.9.1CAS number 1072-84-0
    D.3.9.3Other descriptive name4-imidazole carboxylic acid; 4-carboxyimidazole; 1H-imidazole-4-carboxylic acid
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    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.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
    dermatitis atópica

    (atopic dermatitis)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012438
    E.1.2Term Dermatitis atopic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - to determine the efficacy of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis;
    - to determine the safety and tolerability of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis.
    E.2.2Secondary objectives of the trial
    - to determine the systemic exposure to and urinary excretion of ImCOOH after topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis;
    - to determine the endogenous exposure to and urinary excretion of ImCOOH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged between 18 and 70 years, extremes included.
    2. Skin type I, II, III, or IV.
    3. Able to comply with protocol requirements.
    4. Informed Consent Form (ICF) signed voluntarily before the first trial-related activity.
    5. Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection.
    6. Normal weight as defined by a Quetelet Index (Body Mass Index [BMI]: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included.
    7. Patients having atopic dermatitis according to the integrated list with criteria for atopic dermatitis.
    8. Comparative target areas: minimum 0.1% and maximum 2% of the total body surface area per target area with one site at the left limb and one site at the right limb. Both target areas should be located at the arms (armpits [axillas] are also allowed) or both target areas should be located at the hollows of the knee.
    9. Topical Atopic Dermatitis Severity Index (toADSI) score of at least 5 for both target areas and the severity of the 2 sites does not differ by more than 3 points.
    10. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
    E.4Principal exclusion criteria
    1. Female subject of childbearing potential without use of effective birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period;
    Note: Estrogen based hormonal contraception may not be reliable when ImCOOH cream is applied, therefore to be eligible for this trial, women of childbearing potential should either:
    a. use a double barrier method to prevent pregnancy (i.e., using a condom with either diaphragm or cervical cap);
    b. use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
    c. use an intrauterine device in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
    d. be only non-heterosexually active, practice heterosexual abstinence, or have a vasectomized partner (confirmed sterile).
    Women with tubal ligation are required to use 1 non-hormonal contraceptive method.
    Women who are postmenopausal for at least 2 years, and women with total hysterectomy are considered of non-childbearing potential.
    2. A positive pregnancy test or breast feeding at screening.
    3. A positive HIV-1 or -2 test at trial screening.
    4. Hepatitis B infection (confirmed by hepatitis B surface antigen) or hepatitis C infection (confirmed by hepatitis C virus antibody) at trial screening.
    5. Having a target area that is hairy in such extent that in the investigator’s opinion it could influence the application.
    6. Having a target area that is tattooed.
    7. Unable to take venous blood samples for pharmacokinetics (PK) outside the elbow fold (fossa cubitus) area in case both elbow folds are part of the target areas.
    8. Patients receiving radiation therapy, systemic therapy with cytostatics or immunosuppressive drugs within 24 weeks before the first application of trial medication.
    9. Patients receiving phototherapy or systemic therapy for atopic dermatitis within 4 weeks before the first application of trial medication.
    10. Patients receiving antibiotics or topical therapy for atopic dermatitis within 2 weeks before the first application of trial medication. However, once-daily use of 1% hydrocortisone acetate is allowed on all lesions with the exception of the test sites and emollients are allowed to be used liberally but not on the test sites.
    11. Patients taking antihistamines within 1 week before the first application of trial medication.
    12. Patients with any acute skin infection (superinfection or secondary impetiginisation).
    13. Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the patient safety or compliance with trial procedures.
    14. Any history or currently active allergy such as but not limited to drug allergy, food allergy or hay fever.
    15. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the trial medication administered in this trial.
    16. Participation in an investigational drug trial within 30 days prior to the first application of trial medication.
    17. Donation of blood or plasma in the 60 days preceding the first application of trial medication.
    18. Patients with the following laboratory abnormalities at screening:
    • serum creatinine > 1.1 x ULN;
    • hemoglobin ≤ 10.9 g/dL;
    • platelet count grade ≤ 125 x 109/L;
    • absolute neutrophil count ≤ 1.3 x 109/L;
    • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.25 x ULN;
    • total bilirubin ≥ 1.1 x ULN;
    • proteinuria or hematuria;
    • any other moderate or severe laboratory abnormality.
    E.5 End points
    E.5.1Primary end point(s)
    efficacy, safety, tolerability and pharmacokinetics
    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) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    left-right limb comparison
    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 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
    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 months4
    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 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 state25
    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 Decision2007-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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