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    Summary
    EudraCT Number:2007-004627-38
    Sponsor's Protocol Code Number:ASF-1057-301
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-004627-38
    A.3Full title of the trial
    Efficacy and safety of ASF 1057 cream 0.5% in the treatment of seborrhoeic dermatitis: A phase III randomised, double-blind, vehicle- and placebo controlled, parallel groups, multi-centre trial.
    A.4.1Sponsor's protocol code numberASF-1057-301
    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 SponsorAstion Pharma A/S
    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 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 nameASF-1057 Cream 0.5%
    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 INNglycerylmonocaprylate
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    D.8 Placebo: 2
    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
    Seborrhoeic 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
    The primary objective is to show a superior treatment effect of ASF 1057 cream 0.5% over vehicle and/or placebo on moderate to severe seborrhoeic dermatitis in adult patients following 3 weeks twice daily treatment regimen in terms of responder rate (overall severity score [OSS] ≤ 1 score units).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare and describe the efficacy and safety of ASF 1057 cream 0.5%, vehicle and placebo with regards to:
    • OSS,
    • Erythema,
    • Scaling,
    • Investigator global assessment (IGA) of disease status,
    • Pruritus,
    • Patient global assessment of disease status,
    • Safety and local tolerance profile.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be entered into this trial only if they meet all of the following criteria:
    1. Patients of either sex at least 18 years of age,
    2. A clinical diagnosis of seborrhoeic dermatitis defined as inflamed dermatitis with both erythema and scaling, involving at least the medial part of the eyebrows, and/or the glabella, and/or the nasolabial folds,
    3. Moderate to severe seborrhoeic dermatitis defined as an involvement of at least 4 cm2 skin area with an OSS ≥ 4 score units and a score for erythema ≥ 2 score units:
    Note: The degree of erythema and scaling at inclusion should be predominating throughout the area to be evaluated. It is not sufficient that there is only a small spot in the area with e.g., an erythema score ≥ 2 score units for the patient to be included.
    4. Skin type: I to IV,
    5. Signed and dated informed consent,
    6. Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a medically accepted contraceptive method (and agree to use it during the trial) such as:
    ­ Systemic contraceptive (oral, implant, injection),
    ­ Diaphragm or cervical cap with intravaginal spermicide,
    ­ Intrauterine device.
    In Denmark and Germany, one of these contraceptive regimens must have been used for at least 12 weeks before Visit 2, and the patients must agree to continue their contraception during the trial and for 1 month after the end of the trial.
    7. Willingness and ability to comply with the trial procedures.
    E.4Principal exclusion criteria
    Patients will not be enrolled if they meet any of the following criteria:
    1. Female patients who are pregnant or breast-feeding,
    2. Known allergy to any of the constituents of the product being tested,
    3. Known immunosuppressive (e.g., AIDS/HIV) or neurological diseases (e.g., Parkinson’s disease or MS),
    4. Presence of another serious or progressive disease which, according to the Investigator may interfere with treatment outcome,
    5. Active skin disease such as psoriasis, atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome,
    6. Use of topical medical treatment in the face, e.g., anti inflammatory (e.g., corticosteroids, non-steroidal anti inflammatory drugs [NSAIDs] or calcineurine inhibitors), coal tar preparations, anti-seborrhoeic preparations, antihistamine, antibiotics, or antifungal during the 2 weeks preceding the baseline visit (Day 0),
    7. Use of systemic medical treatment:
    a. Anti-inflammatory drugs (e.g., calcineurine inhibitors), antihistamines, antibiotics, antifungals during the 2 weeks before the baseline visit (Day 0),
    b. Corticosteroids and immunosuppressant treatment during the 4 weeks preceding the baseline visit (Day 0),
    c. Retinoids during the 6 months preceding the baseline visit (Day 0),
    8. Planned change in hygiene habits and toilet products in the face during the trial,
    9. Planned extensive sun exposure during trial participation (i.e., sun exposure leading to reddening of the skin),
    10. Planned use of cosmetic products on the area to be treated such as; moisturizer, cleanser, facemasks, peeling creams and acne-stick or any other stick used to mask pimples during treatment period,
    11. Participation in another clinical trial during the last month preceding the baseline visit (Day 0).
    E.5 End points
    E.5.1Primary end point(s)
    Percentages of responders (patients with OSS ≤ 1 score units) at Visit 5 will be tabulated by treatment group. Two-sided 95% CIs for these proportions will be calculated by Wilson’s method. 2 sided 95% CIs for the pair-wise differences of the proportions (ASF 1057 minus vehicle, ASF-1057 minus placebo and placebo minus vehicle) will be computed by Newcombe’s method.
    ASF-1057 will be compared to the control treatments using a hierarchical testing scheme: In step 1, ASF-1057 will be statistically significantly superior to vehicle, if the 2-sided p-value of the χ2 test for ASF-1057 versus vehicle does not exceed 0.05 and the estimated response rate of ASF-1057 is larger than the vehicle response rate. If a statistically significant superiority to vehicle could be shown in step 1, then a statistically significantly superiority of ASF-1057 versus placebo will be concluded in step 2, if the 2-sided p-value of the χ2 test for ASF-1057 versus placebo does not exceed 0.05 and the estimated response rate of ASF-1057 is larger than the placebo response rate. This hierarchical testing procedure will constitute the confirmatory analysis. All other analyses will be regarded as exploratory.
    The p-value of the χ2 test for the comparison of the placebo and vehicle response rates will also be calculated.
    The percentages of responders in the 3 treatment groups will also be presented stratified by randomisation stratification factors, and in a separate analysis stratified by baseline OSS.
    Additionally, the p-value of the Cochran-Mantel-Haenszel test, adjusted for randomisation stratification factors, will be calculated for the 3 comparisons “ASF 1057 versus vehicle”, “ASF 1057 versus placebo” and “placebo versus vehicle”.
    In the above analyses, patients without any post-baseline OSS will be regarded as non responders. For other patients without OSS at Visit 5, the last non-missing post baseline OSS will be carried forward.
    In alternative sensitivity analyses, patients without OSS score at Visit 5 who were not withdrawn due to treatment failure will be excluded from the analysis.
    In a further sensitivity analysis, all patients without OSS at Visit 5 will be regarded as non responders.
    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) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vehicle without nicotinamide (barrier enhancer)
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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.1.3Elderly (>=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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 500
    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 Decision2007-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-15
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