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    Summary
    EudraCT Number:2011-002464-24
    Sponsor's Protocol Code Number:ESA-13/2010
    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:2011-06-17
    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 number2011-002464-24
    A.3Full title of the trial
    Clinical study to investigate the efficacy and safety of an estradiol containing cream
    (0.01 % estradiol) in patients with dermatoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to investigate the efficacy and safety of an estradiol containing cream
    (0.01 % estradiol) in patients with senile skin
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of estradiol on dermatoporosis
    A.4.1Sponsor's protocol code numberESA-13/2010
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDr. August Wolff GmbH & Co. KG Arzneimittel
    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 supportDr. August Wolff GmbH & Co. KG Arzneimittel
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. August Wolff GmbH & Co. KG
    B.5.2Functional name of contact pointSabine Müller-Röhr
    B.5.3 Address:
    B.5.3.1Street AddressSudbrackstr. 56
    B.5.3.2Town/ cityBielefeld
    B.5.3.3Post code33611
    B.5.3.4CountryGermany
    B.5.4Telephone number004905218808420
    B.5.5Fax number004905218808474
    B.5.6E-mailsabine.mueller-roehr@wolff-arzneimittel.de
    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 Linoladiol N
    D.2.1.1.2Name of the Marketing Authorisation holderDr. August Wolff GmbH & Co. KG Arzneimittel
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameESTRADIOL HEMIHYDRATE
    D.3.9.4EV Substance CodeSUB11941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01033
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    dermatoporosis stage I and II
    E.1.1.1Medical condition in easily understood language
    mild to moderate senile skin
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    Comparison of test product and placebo on changes of epidermis thickness to baseline after 8 weeks of treatment as measured with a vivascope
    E.2.2Secondary objectives of the trial
    •Thickness of epidermis (vivascope) at baseline, after 4 weeks of treatment and follow-up visit
    •Skin elasticity (Cutometer) at baseline, after 4 and 8 weeks of treatment and follow-up visit
    •Phase shift rapid in vivo measurements of skin at baseline, after 4 and 8 weeks of treatment and follow-up visit
    •Thickness of skin (22MHz ultrasound) at baseline, after 4 and 8 weeks of treatment and follow-up visit
    •Clinical assessment of skin atrophy (investigator)
    •Changes in senile purpura, pseudo scars and if applicable skin laceration
    •Tolerability assessed after 2, 4, 6 and after 8 weeks of treatment by study personnel and patient
    •Self assessment of skin fragility
    •Skin histology
    •Laboratory parameters: FSH, LH and estradiol at baseline, after 12, 14 and 16 days of treatment as well as after 8 weeks of treatment
    •Explorative: count of papillae (Vivasope), if possible, at baseline, after 4 and 8 weeks of treatment and at the follow-up visit
    •Safety parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •dermatoporosis stage I or II, i.e at least the presence of the following symptoms: skin atrophy and senile purpura or pseudo scar, otherwise healthy skin
    •Skin thickness < 1mm as measured by ultrasound
    •Clinical assessment of skin atrophy of ≥ 2
    •Postmenopausal women with last menstruation > 24 months prior study start
    •Serum estradiol < 30 pg/ml l
    •skin type II to IV (Fitzpatrick) , I may be also included
    •≥ 60 years old
    •Willingness to actively participate in the study and to come to the scheduled visits
    •Signed written informed consent
    •Willingness to discontinue the use of own cleansing and cosmetic products in the treatment areas throughout the course of the study
    E.4Principal exclusion criteria
    -Systemic treatment with drugs interfering with the immune system (in brackets: months prior to study day 1 and during conduct of study) : corticosteroids (3), estrogen or gestagen containing drugs or exogenous steroid hormones (1), use of estragen of gestagen injections (6), nonsteroidal anti-inflammatory drugs (0.5; The intake acetylisalicylic acid is permitted if low-dose prophylaxis or occasional intake for minor pain relief), anticoagulant intake (3)
    -Topical treatment of test areas: corticosteroids (3), anti-inflammatory substances (0.5), any of the test preparations tested in this study (1)
    -Diseases: atopic dermatitis, eczema, rosacea, allergic asthma bronchiale, hyper- or hypotension, bradycardia or bradyarrhytmia, tachycardia or tachyarrhythmia, chronic liver disease, estrogen dependent neoplasia, class III, IV or V Papanicolaou smear or evidence of cervical dysplasia, lyomyoma or endometriosis, sickle cell anaemia, osteosclerosis, idiopathic icterus, acute infection, active skin disease, e.g. skin tumors, keloids formation, hypertrophic scarring, moderate or severe illness within the last 2 weeks before first exposure, known infectious diseases, thromboemboembolic disorders or coagulation disorders
    -Known hypersensitivity against: one of the ingredients of the product, latex, local anesthetics or plasters
    E.5 End points
    E.5.1Primary end point(s)
    Change of epidermal thickness to baseline measured after 8 weeks of treatment with a vivascope.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 8 weeks of treatment
    E.5.2Secondary end point(s)
    •Change of epidermal thickness to baseline measured after 4 weeks of treatment and after 12 weeks (follow-up visit) with a vivasope
    •Changes of skin elasticity parameter R7 (Ur/Uf: elastic relaxation to total elasticity) to baseline after 4 and 8 weeks of treatment and at the follow-up visit (after 12 weeks) measured with Cutometer
    •Morphological structure of skin: Changes for parameters Rz, Ra to baseline, after 4 and 8 weeks of treatment and at the follow-up visit (after 12 weeks) measured with PRIMOS
    •Changes in skin thickness to baseline, as measured with by 22MHz ultrasound after 4 and 8 weeks of treatment and at the follow-up visit (after 12 weeks)
    •Clinical assessment of skin atrophy (investigator), at baseline, 4 and 8 weeks after treatment and at final visit
    •Changes in senile purpura, pseudo scars and if applicable skin laceration (clinical photography at baseline and after 8 weeks of treatment)
    •Tolerability assessed after 2, 4, 6 and after 8 weeks of treatment by study personnel and patient
    •Self assessment of skin fragility by patients once weekly
    •Skin histology (PE, 4 mm punch biopsy at baseline and after 8 weeks of treatment):
    Immunohistochemistry: HE (tissues), collagen I + III, EVG
    •Laboratory parameters: FSH, LH and estradiol at baseline, after 12, 14 and 16 days of treatment as well as after 8 weeks of treatment
    •Safety parameters (e.g. adverse events, blood safety parameters)
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 8 weeks of treatment
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    intraindividual 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.8.2.4Number of treatment arms in the trial1
    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 No
    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
    The end of the trial is defined as the last visit of the last patient after the follow-up period.
    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 months3
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    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.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state44
    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)
    A follow-up period of 4 weeks is planned. However, a treatment after study termination is not foreseen.
    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 Decision2011-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-14
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