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    Summary
    EudraCT Number:2018-003630-33
    Sponsor's Protocol Code Number:ERGO45359
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-003630-33
    A.3Full title of the trial
    Spironolactone for Adult Female Acne: A pragmatic multicentre double-blind randomised superiority trial to investigate the clinical and cost-effectiveness of spironolactone for moderate or severe persistent acne in women
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Spironolactone for Adult Female Acne
    A.3.2Name or abbreviated title of the trial where available
    Spironolactone for Adult Female Acne
    A.4.1Sponsor's protocol code numberERGO45359
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12892056
    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 SponsorUniversity of Southampton
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Southampton
    B.5.2Functional name of contact pointSouthampton Clinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressMP131, Southampton General Hospital
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02381205596
    B.5.6E-mailsafa@soton.ac.uk
    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 Spironolactone ratiopharm® 50 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    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.3.1Product nameSpironolactone ratiopharm® 50 mg tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSpironolactone
    D.3.9.1CAS number 52-01-7
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acne of sufficient severity to warrant treatment with oral antibiotics.
    E.1.1.1Medical condition in easily understood language
    Acne bad enough that a doctor would prescribe oral antibiotics to treat it.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000496
    E.1.2Term Acne
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study will measure whether spironolactone plus standard care is better than placebo plus standard care for adult women (18 years or older) with persistent acne that would normally be treated with oral antibiotics.

    This will be measured using a participant-reported acne-specific Quality of Life questionnaire (Acne-QoL) at 12 weeks.
    E.2.2Secondary objectives of the trial
    1. To see if spironolactone plus standard care is better for acne than placebo plus standard care, after 24 weeks.
    2. To see how much treating a person's acne with spironolactone for 24 weeks costs.
    3. To see if using spironolactone to treat acne is safe.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploring the role of androgens and sebum production as a mechanism for spironolactone reducing acne severity: A mechanistic sub-study of the Spironolactone for Adult Female Acne (SAFA) RCT.

    Aims
    1. Investigate whether women with hyperandrogenism gain greater benefit from the treatment of acne with spironolactone
    2. Explore the mechanism of action of spironolactone by analysing biochemical hyperandrogenism at baseline and 12 weeks
    3. Explore the mechanism of action of spironolactone by analysing sebum production at baseline and 12 weeks

    Methods
    1. Measure serum total testosterone, sex hormone binding globulin (SHBG), free androgen index, androstenedione and dehydroepiandrosterone sulfate (DHEAS) at baseline in order to assess biochemical hyperandrogenism.
    2. Repeat serum total testosterone, SHBG, free androgen index, androstenedione and DHEAS at 12 weeks to monitor hormonal changes in response to spironolactone
    3. Monitor sebum production on the same acne affected site using sebutape analysis at baseline and 12 weeks

    Funding is being sought from the NIHR EME Programme Mechanisms of Action of Heath Interventions call.
    E.3Principal inclusion criteria
    - Women aged 18 years or over
    - Facial acne, symptoms present since at least 6 months
    - Acne of sufficient severity to warrant treatment with oral antibiotics, as judged by the study clinician
    - Women of childbearing potential at risk of pregnancy must be willing to use their usual hormonal or barrier method of contraception for the first 6 months of the study
    - Willing to be randomised to either study group
    - Willing and able to give informed consent
    - Sufficient English to carry out primary outcome Acne-QoL (which has not been validated in other languages)
    E.4Principal exclusion criteria
    - Serum potassium above the upper limit of the reference range for the laboratory processing the test (measured at the baseline clinic visit)
    - eGFR below 60 ml/min/1.73m2
    - Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
    - Acne grade 0-1 using the Investigator’s Global Assessment (i.e. clear or almost clear)
    - Currently taking potassium-sparing diuretic, ACE inhibitor, angiotensin II receptor blocker or digoxin
    - Started, stopped or changed long-term (lasting more than 2 weeks) hormonal contraception, co-cyprindiol or other hormonal treatment within the past 3 months
    - Planning to start, stop or change long-term hormonal contraception, co-cyprindiol or other hormonal treatment within the next 3 months
    - Pregnant/breastfeeding
    - Intending to become pregnant in the next 6 months
    - Androgen-secreting adrenal or ovarian tumour
    - Cushing’s syndrome
    - Congenital adrenal hyperplasia
    - Oral antibiotic treatment (lasting longer than a week) for acne within the past month
    - Oral isotretinoin treatment within the past 6 months
    E.5 End points
    E.5.1Primary end point(s)
    Acne-QoL symptom subscale score at 12 weeks.

    The analysis will be carried out in the Intention-to-treat population.

    The primary analysis will be of the mean difference between the groups on the Acne-QoL symptom subscale at 12 weeks in a linear regression model, adjusting for baseline variables (including baseline Acne-QoL symptom subscale score, use of topical treatments and use of hormonal contraception/co-cyprindiol) and randomisation stratification variables (centre and baseline severity (IGA < 3 versus 3 or more)). A 95% confidence interval for the least squares mean difference between arms in Acne-QoL symptom subscale at 12 weeks will be calculated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks.
    E.5.2Secondary end point(s)
    1. Acne-QoL symptom subscale score
    2. Acne-QoL other subscales (self-perception, role-emotional and role-social) and total score
    3. Participant self-assessed improvement recorded on a 6-point Likert scale (with baseline photograph to assist recall)
    4. Investigator’s Global Assessment
    5. Participant’s Global Assessment
    6. Participant satisfaction with study treatment
    7. Health-related quality of life using EQ-5D-5L
    8. Cost and cost-effectiveness
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 6 and 24 weeks
    2. 6, 12 and 24 weeks
    3. 6, 12 and 24 weeks
    4. 6, 12 and 24 weeks
    5. 6, 12 and 24 weeks
    6. 24 weeks (prior to unblinding)
    7. 6, 12 and 24 weeks
    8. 6, 12 and 24 weeks
    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 No
    E.6.5Efficacy No
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    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 Yes
    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
    End of study is defined as when the last point of data is collected for the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 433
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state434
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 434
    F.4.2.2In the whole clinical trial 434
    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)
    Participants in either arm may seek to use spironolactone after 24 weeks. We will send a letter to all participants and one to their GPs informing them which treatment the participant received. The letter will suggest potential action for the GP, if their patient asks to be prescribed spironolactone.

    If SAFA is successful, we would expect NICE to incorporate SAFA's results and update their guidelines; making spironolactone an option for standard care for adult women with persistent acne.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Southampton CTU
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-10
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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