Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41039   clinical trials with a EudraCT protocol, of which   6717   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An antimicrobial cream for the treatment of impetigo

    Summary
    EudraCT number
    2008-000036-41
    Trial protocol
    GB  
    Global end of trial date
    27 Feb 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Mar 2021
    First version publication date
    12 Mar 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    IPTG-01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dermal Laboratories Limited
    Sponsor organisation address
    Tatmore Place, Gosmore, Hitchin, United Kingdom, SG4 7QR
    Public contact
    Sue Dean, Dermal Laboratories Ltd, 44 01462 458866, clinical@dermal.co.uk
    Scientific contact
    Sue Dean, Dermal Laboratories Ltd, 44 01462 458866, clinical@dermal.co.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was: • to determine whether IPTG Cream is efficacious in the treatment of primary non-bullous impetigo, using a non-inferiority study design based on the treatment effect of Fucidin Cream from a previous placebo-controlled study.
    Protection of trial subjects
    Once a potential patient was identified for the study, a Patient Information Sheet was provided to the patient and/or their parent/guardian to read through before considering participation in the study, and to keep for review during the study. In addition to the normal style and format used for adults, child-friendly versions specifically tailored for 6 to 7 years, 8 to 10 years, and 11 to 15 years, were used. For children below the age of 6 years, the study was explained to the child patient verbally, using language suitable for their capacity of understanding. Once the potential participant fully confirmed their understanding of the requirements for the study and their questions or queries regarding the trial were satisfactorily answered and they agreed to participate, written, signed, fully informed consent was then taken. All patients aged 16 years and above signed an Informed Consent Form prior to their involvement in the study. For patients less than 16 years, their parent/guardian signed an Informed Consent Form to confirm that they were volunteering their fully informed consent for their child to enter the study. Those patients under 16 years of age, deemed capable of giving their assent to take part in the study, were also asked to sign an Assent Form.
    Background therapy
    Patients were instructed to gently cleanse the affected areas before the initial application, as long as this did not cause discomfort and then to apply enough of the cream provided (either IPTG or Fucidin) to gently rub into the impetigo affected area(s) and immediately surrounding skin, three times daily for the full 7 day treatment period (21 treatments in all) following the instructions provided in the Product Information Leaflet within the Treatment Diary. Patients were instructed not to cover their impetigo lesions with dressings, bandages and/or nappies etc. while treating these areas.
    Evidence for comparator
    Fucidin Cream was a suitable comparator because, despite recent concerns about emerging bacterial resistance, it was, at the time the study was designed and implemented, the standard first line treatment in this indication as recommended by NICE and its effectiveness has been demonstrated in a number of good quality published studies, including the key placebo controlled study used for the determination of the non-inferiority margin for the primary efficacy objective (Koning et al, 2002). In addition, Fucidin is a white cream formulation which enables the study to be designed as a double-blind comparison.
    Actual start date of recruitment
    16 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 273
    Worldwide total number of subjects
    273
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    10
    Children (2-11 years)
    148
    Adolescents (12-17 years)
    14
    Adults (18-64 years)
    87
    From 65 to 84 years
    12
    85 years and over
    2

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Recruitment was opportunistic, involving patients presenting for treatment at 28 GP centres across the UK.

    Pre-assignment
    Screening details
    276 potential participants were consented and screened, of whom 3 were found to be ineligible. The remaining 273 patients were randomised. Six patients were excluded from the full ITT analysis set.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fucidin group
    Arm description
    Patients allocated to receive fucidin cream.
    Arm type
    Active comparator

    Investigational medicinal product name
    Fucidin cream (2% fusidic acid)
    Investigational medicinal product code
    PL 00043/0065
    Other name
    Fucidic acid cream 20 mg/g
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Fucidin cream, topically applied three times daily, for 7 days. Enough fucidin cream to gently rub into the impetigo affected areas and immediate surrounding skin.

    Arm title
    IPTG group
    Arm description
    Patients allocated to receive IPTG cream.
    Arm type
    Experimental

    Investigational medicinal product name
    IPTG cream
    Investigational medicinal product code
    Other name
    IPTG cream: Chlorhexidine dihydrochloride 0.1% w/w Benzalkonium chloride 0.1% w/w Isopropyl Myristate 10% w/w Liquid paraffin 10% w/w
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    IPTG Cream, topically applied three times daily, for 7 days. Enough IPTG Cream to gently rub into the impetigo affected areas and immediate surrounding skin.

    Number of subjects in period 1
    Fucidin group IPTG group
    Started
    137
    136
    Completed
    112
    106
    Not completed
    25
    30
         Randomised twice in error
    1
    -
         Serious breach
    2
    3
         No longer willing/able to attend
    4
    6
         Disallowed medication to prevent recurrence
    2
    1
         Adverse event, non-fatal
    2
    1
         Used disallowed emollient on impetigo
    2
    2
         Disallowed medication for a different condition
    1
    2
         Not invited back to V3
    1
    1
         Lost to follow-up
    4
    5
         Impetigo disease progression
    6
    9

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Fucidin group
    Reporting group description
    Patients allocated to receive fucidin cream.

    Reporting group title
    IPTG group
    Reporting group description
    Patients allocated to receive IPTG cream.

    Reporting group values
    Fucidin group IPTG group Total
    Number of subjects
    137 136 273
    Age categorical
    Units: Subjects
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    4 6 10
        Children (2-11 years)
    76 72 148
        Adolescents (12-17 years)
    7 7 14
        Adults (18-64 years)
    43 44 87
        From 65-84 years
    5 7 12
        85 years and over
    2 0 2
    Gender categorical
    Units: Subjects
        Female
    85 74 159
        Male
    52 62 114

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Fucidin group
    Reporting group description
    Patients allocated to receive fucidin cream.

    Reporting group title
    IPTG group
    Reporting group description
    Patients allocated to receive IPTG cream.

    Primary: Clinical response at end of treatment (EOT)

    Close Top of page
    End point title
    Clinical response at end of treatment (EOT)
    End point description
    The Primary Efficacy Parameter was the clinical response, i.e. success or failure, at the EOT visit, after the end of the seven-day treatment period. As defined by Oranje et al. (2007): Clinical success at EOT was defined as: • a total absence of treated lesions, or • the treated lesions have become dry without crusts, with or without erythema, compared with appearance at baseline, or • the lesions show improvement (defined as a decrease in the size of the affected area, number of lesions, or both) so that no further antimicrobial/antibacterial therapy is deemed necessary by the Investigator. Clinical failure at EOT was defined as: • deterioration of condition, or • insufficient improvement (i.e. lesions remain crusted and / or have exudate leaving a yellow or honey coloured crust, or the lesion area(s) has increased from baseline, with or without an increase in the number of lesions), so that additional antimicrobial/antibacterial therapy is required.
    End point type
    Primary
    End point timeframe
    Clinical response was assessed at the EOT visit (Day 8). A clinical response of 'clinical failure' prior to the EOT visit was carried forward to that visit.
    End point values
    Fucidin group IPTG group
    Number of subjects analysed
    115 [1]
    116 [2]
    Units: Number of patients
    97
    87
    Notes
    [1] - Per Protocol Analysis Set
    [2] - Per Protocol Analysis Set
    Statistical analysis title
    Difference in success: Fucidin - IPTG
    Statistical analysis description
    A one sided 2.5% significance level (Type I Error rate) was used in this non-inferiority study design, corresponding to the use of a 95% confidence interval for the difference in percentage of patients with clinical response of success between the two treatments, where the upper bound of the interval for the difference (Fucidin-IPTG) was of interest.
    Comparison groups
    Fucidin group v IPTG group
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    9.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    19.6
    Notes
    [3] - 75% of patients treated with IPTG cream were classed as clinical success compared to 84% of patients treated with Fucidin. This is a difference of 9.4%. The M1 non-inferiority margin for the primary objective is 16 percentage points. Since the upper bound of the two-sided 95% confidence interval for the difference in percentage of patients with clinical response of success between the two treatments (Fucidin-IPTG) was more than 16 percentage points, the primary objective was not met.

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From consent through to follow-up visit.
    Adverse event reporting additional description
    Safety results are reported using the Safety Analysis Set and according to the actual study treatment received rather than the randomised treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Fucidin group
    Reporting group description
    Safety results are reported using the Safety Analysis Set and according to the actual study treatment received rather than the randomised treatment.

    Reporting group title
    IPTG group
    Reporting group description
    Safety results are reported using the Safety Analysis Set and according to the actual study treatment received rather than the randomised treatment.

    Serious adverse events
    Fucidin group IPTG group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 136 (0.00%)
    0 / 137 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Fucidin group IPTG group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 136 (22.79%)
    49 / 137 (35.77%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    6 / 136 (4.41%)
    4 / 137 (2.92%)
         occurrences all number
    6
    4
    Pain
         subjects affected / exposed
    0 / 136 (0.00%)
    2 / 137 (1.46%)
         occurrences all number
    0
    3
    Feeling hot
         subjects affected / exposed
    1 / 136 (0.74%)
    2 / 137 (1.46%)
         occurrences all number
    1
    2
    Pyrexia
         subjects affected / exposed
    1 / 136 (0.74%)
    2 / 137 (1.46%)
         occurrences all number
    1
    2
    Application site erythema
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Application site pain
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Application site pruritus
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    application site redness
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Inflammation
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Swelling
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Perineal pain
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Skin injury
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Body temperature increased
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Intraocular pressure increased
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 136 (0.74%)
    3 / 137 (2.19%)
         occurrences all number
    1
    3
    Oropharyngeal pain
         subjects affected / exposed
    1 / 136 (0.74%)
    4 / 137 (2.92%)
         occurrences all number
    1
    4
    Asthma
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    cough
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 137 (0.73%)
         occurrences all number
    1
    1
    Nasal discomfort
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    2
    Rhinalgia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 136 (3.68%)
    6 / 137 (4.38%)
         occurrences all number
    5
    6
    Paraesthesia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 136 (0.00%)
    2 / 137 (1.46%)
         occurrences all number
    0
    2
    Teething
         subjects affected / exposed
    1 / 136 (0.74%)
    2 / 137 (1.46%)
         occurrences all number
    1
    2
    Vomiting
         subjects affected / exposed
    2 / 136 (1.47%)
    1 / 137 (0.73%)
         occurrences all number
    2
    1
    Abdominal discomfort
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Cheilitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 137 (0.73%)
         occurrences all number
    1
    1
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Oral pain
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 136 (0.74%)
    4 / 137 (2.92%)
         occurrences all number
    2
    5
    Rash
         subjects affected / exposed
    0 / 136 (0.00%)
    2 / 137 (1.46%)
         occurrences all number
    0
    2
    Dry skin
         subjects affected / exposed
    0 / 136 (0.00%)
    6 / 137 (4.38%)
         occurrences all number
    0
    6
    Eczema
         subjects affected / exposed
    2 / 136 (1.47%)
    1 / 137 (0.73%)
         occurrences all number
    2
    1
    Skin lesion
         subjects affected / exposed
    2 / 136 (1.47%)
    0 / 137 (0.00%)
         occurrences all number
    2
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Rash erythematous
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Skin haemorrhage
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 137 (0.73%)
         occurrences all number
    1
    1
    Skin irritation
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Skin reaction
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 137 (0.73%)
         occurrences all number
    1
    1
    Skin swelling
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Osteitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 136 (1.47%)
    3 / 137 (2.19%)
         occurrences all number
    2
    3
    Body tinea
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Ear lobe infection
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Omphalitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Tinea pedis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 137 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 137 (0.73%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1
    Varicella
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 137 (0.73%)
         occurrences all number
    0
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2018
    This amendment allowed for: • the implementation of a new recruitment strategy which included the ability of investigators to recruit patients not registered with their practice in order to address the recruitment challenges posed by the opportunistic nature of impetigo patients. However, no patients were actually recruited who were not registered at the Investigator site practice and therefore this part of the amendment has no implications for the interpretation of the study. • Investigators to delegate roles, specifically including the EOT and Follow-Up clinical assessments, to be performed by qualified Nurse Practitioners who were considered by the Investigator to be suitably experienced. Note that the Nurse Practitioners were not permitted to conduct patient eligibility or safety assessments. • minor changes to facilitate study management at the investigative sites. This amendment was managed by, and documented within, the company’s Study Amendment control procedure, and REC, MHRA and HRA approval gained before implementation. There were no changes to the inclusion/exclusion criteria.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA