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    Summary
    EudraCT Number:2006-002833-19
    Sponsor's Protocol Code Number:SPD488-402
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-10-11
    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 ConcernedAustria - BASG
    A.2EudraCT number2006-002833-19
    A.3Full title of the trial
    A randomised, multi-centre, open-label study to evaluate the efficacy of VANIQA with laser treatment versus laser treatment alone in female subjects with excessive facial hair (facial hirsutism)
    A.4.1Sponsor's protocol code numberSPD488-402
    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 SponsorShire Pharmaceutical Development
    B.1.3.4CountryUnited Kingdom
    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 Vaniqa 11.5% Cream
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceutical Contracts Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEflornithine 115mg
    D.3.9.1CAS number 96020-91-6
    D.3.9.3Other descriptive namehydrochloride monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number115
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Excessive facial hair in females (Facial hirsutism)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10020112
    E.1.2Term Hirsutism
    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 the efficacy of twice-daily application of eflornithine 11.5% cream with laser treatment in the treatment of women with excessive facial hair growth on upper lip and chin, by measuring cumulative length of hair (total length of all visulised hairs added together) within a pre-defined area of the upper lip. It will be measured by using digital image analysis (Trichoscan), and compared to a contol group receiving laser treatment alone.
    E.2.2Secondary objectives of the trial
    - To evaluate efficacy by measuring mean hair thickness on upper lip, as measured by digital image analysis (Trichoscan).
    - To evaluate efficacy by measuring mean growth rate of hair on upper lip, as measured by digital image analysis (Trichoscan)
    - To evaluate efficacy by blinded central assessment of a photographic image of the lower face.
    - To evaluate overall subject satisfaction using a subject self-assessment questionnaire.
    - To evaluate safety by recording adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female subjects aged 18 or over
    - Satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history or physical exam)
    - Clinical diagnosis of facial hirsutism/excessive facial hair
    - Subjects with Fitzpatrick skin type I- IV
    - For effective photoepilation skin/hair contrast must be adequate (hair in target areas to be predominantly brown or black in colour)
    E.4Principal exclusion criteria
    - Use of electrolysis or epilation (plucking, waxing, Epilady, sugaring etc.) to remove hair within 6 weeks before start of study or regular use of any other medication that could affect (improve or worsen) the condition being studied, or could affect the action, absorption or disposition of the investigational product or clinical assessments
    - Use of laser to remove hair within 6 months before start of study
    - Facial conditions such as severe inflammatory acne
    - Use of systemic antiandrogens, growth hormone, insulin-sensitising agents, spironolactone, immunostimulants, immunosuppressants, dehydroepiandosterone (DHEA), minoxidil, flutamide or other medications considered to have an effect on hair growth with 6 months of the study
    - Change of oral contraceptive with 6 months prior to screening
    - Use of concomitant therapy with any medication considered to exacerbate or be useful treatment of hirsutism including ketoconazole. Cyproterone acetate use is allowed up to a maximum dose of 2mg per day.
    - Presence of significant scarring, haemangioma, melanocytic naevi or any other abnormalities in the Trichoscan reference area
    - Hepatic/ renal impairment
    - History of skin malignancy
    - A history of androgen secreting tumour
    - A known severe hyperandrogenaemia or hormonal imbalance requiring or likely to require systemic treatment during the course of the study
    - Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening
    - Subjects must not have used any other investigational product or taken part in a clinical trial within the last 30 days prior to randomisation
    - Known or suspected intolerance or hypersensitivity to the investigational products or any stated ingredients
    - Systemic or topical treatment with phenytoin, retinoids, ciclosporin or corticosteroids
    - Current or recurrent disease that could affect the site of application, the action, absorption or disposition of the investigational product or clinical asessments
    - Patients will not be permitted to use plucking as a method to remove facial hair for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of twice-daily application of eflornithine 11.5% cream with laser treatment in the treatment of women with excessive facial hair growth on upper lip and chin, by measuring cumulative length of hair (total length of all visulised hairs added together) within a pre-defined area of the upper lip. It will be measured by using digital image analysis (Trichoscan), and compared to a contol group receiving laser treatment alone
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    IMP with and without laser treatment
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    The study ends when the last patient who entered into the optional 12 week extension study receives their follow up telephone call 4 weeks after receiving the last application of the investigational product.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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) No
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 200
    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 Decision2006-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-11-03
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