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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44353   clinical trials with a EudraCT protocol, of which   7380   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:
    The risk of an elevated intraocular pressure after treatment with topical corticosteroids in the periocular region

    Summary
    EudraCT number
    		 2020-000252-35
    Trial protocol
    		 DK  
    Global end of trial date
    31 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Aug 2025
    First version publication date
    02 Aug 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DA-TCS-AD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lone Skov
    Sponsor organisation address
    Gentofte Hospitalsvej 15, 1. floor, Gentofte, Denmark, 2820
    Public contact
    Department of Dermatology , Gentofte Hospital, diva.amiri@regionh.dk
    Scientific contact
    Department of Dermatology , Gentofte Hospital, lone.skov.02@regionh.dk
    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
    19 Mar 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to evaluate whether daily treatment with topical corticosteroids in the periocular region causes a change in comparison to the control group.
    Protection of trial subjects
    Participants would be monitored for any unacceptable side effects or increase in eye pressure. Monitoring would continue until the pressure had returned to normal. An additional follow-up examination would be offered if the participant wished for it. If there was an increase in eye pressure, a slit-lamp examination would be offered and performed by Professor, Chief Physician, PhD Miriam Kolko. This examination would take place before the trial concluded.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were included from October 2021 to August 2023 at Department of Dermatology and Allergy, Herlev-Gentofte Hospital.

    Pre-assignment
    Screening details
    		 Inclusion criteria were periocular AD, age 18–75 years and body mass index (BMI) <30 kg/m2. Exclusion criteria were systemic corticosteroid treatments within four weeks before study start, pregnancy, corticosteroid-requiring inflammatory eye diseases, allergy towards interventions, diagnosed diseases that may affect or be affected by the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Hydrocortisone cream 1% (AD)
    Arm description
    		 Patients with periocular AD assessed with Eczema Area and Severity Index (EASI)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mildison Lipid 1% cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Third of an index fingertip unit of hydrocortisone cream 1% around the eyes once daily for four weeks.

    Arm title
    		 Hydrocortison-17-butyrat 0.1% (AD)
    Arm description
    		 Patients with periocular AD assessed with Eczema Area and Severity Index (EASI)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Locoid Lipid 0.1 % cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Third of an index fingertip unit of hydrocortisone-17-butyrat cream 0.1% cream around the eyes once daily for four weeks.

    Arm title
    		 Control
    Arm description
    		 Healthy untreated controls
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Hydrocortisone cream 1% (Healthy)
    Arm description
    		 Healthy treated controls.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mildison Lipid 1% cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Third of an index fingertip unit of hydrocortisone cream 1% around the eyes once daily for four weeks.

    Arm title
    		 Hydrocortison-17-butyrat 0.1% (Healthy)
    Arm description
    		 Healthy treated controls
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Locoid Lipid 0.1 % cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Third of an index fingertip unit of hydrocortisone-17-butyrat cream 0.1% cream around the eyes once daily for four weeks.

    Number of subjects in period 1
    		Hydrocortisone cream 1% (AD) Hydrocortison-17-butyrat 0.1% (AD) Control Hydrocortisone cream 1% (Healthy) Hydrocortison-17-butyrat 0.1% (Healthy)
    Started
    4
    4
    8
    3
    5
    Completed
    4
    4
    8
    3
    5

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Hydrocortisone cream 1% (AD)
    Reporting group description
    		 Patients with periocular AD assessed with Eczema Area and Severity Index (EASI)

    Reporting group title
    Hydrocortison-17-butyrat 0.1% (AD)
    Reporting group description
    		 Patients with periocular AD assessed with Eczema Area and Severity Index (EASI)

    Reporting group title
    Control
    Reporting group description
    		 Healthy untreated controls

    Reporting group title
    Hydrocortisone cream 1% (Healthy)
    Reporting group description
    		 Healthy treated controls.

    Reporting group title
    Hydrocortison-17-butyrat 0.1% (Healthy)
    Reporting group description
    		 Healthy treated controls

    Reporting group values
    		 Hydrocortisone cream 1% (AD) Hydrocortison-17-butyrat 0.1% (AD) Control Hydrocortisone cream 1% (Healthy) Hydrocortison-17-butyrat 0.1% (Healthy) Total
    Number of subjects
    		 4 4 8 3 5 24
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.0 ( 12.1 ) 30.0 ( 8.7 ) 33.5 ( 8.2 ) 25.3 ( 3.5 ) 30.6 ( 10.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 3 5 2 3 15
        Male
    		 2 1 3 1 2 9
    Body Mass Index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 23.8 ( 1.5 ) 23.6 ( 4.0 ) 24.0 ( 3.0 ) 22.8 ( 4.4 ) 22.1 ( 5.8 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Hydrocortisone cream 1% (AD)
    Reporting group description
    		 Patients with periocular AD assessed with Eczema Area and Severity Index (EASI)

    Reporting group title
    Hydrocortison-17-butyrat 0.1% (AD)
    Reporting group description
    		 Patients with periocular AD assessed with Eczema Area and Severity Index (EASI)

    Reporting group title
    Control
    Reporting group description
    		 Healthy untreated controls

    Reporting group title
    Hydrocortisone cream 1% (Healthy)
    Reporting group description
    		 Healthy treated controls.

    Reporting group title
    Hydrocortison-17-butyrat 0.1% (Healthy)
    Reporting group description
    		 Healthy treated controls

    Primary: Change in intraocular pressure

    		 Close Top of page
    End point title
    		 Change in intraocular pressure
    End point description
    The primary endpoint was change in intraocular pressure during four weeks of once daily periocular treatment with hydrocortisone cream 1% or hydrocortisone-17-butyrat cream 0.1% in patients with periocular AD and healthy adults.
    End point type
    Primary
    End point timeframe
    Two, three and four weeks after the first visit intraocular pressure was measured
    End point values
    		 Hydrocortisone cream 1% (AD) Hydrocortison-17-butyrat 0.1% (AD) Control Hydrocortisone cream 1% (Healthy) Hydrocortison-17-butyrat 0.1% (Healthy)
    Number of subjects analysed
    4
    4
    8
    3
    5
    Units: mmHg
        number (confidence interval 95%)
    15.0 (12.3 to 17.7)
    15.0 (12.3 to 17.7)
    14.2 (11.5 to 16.9)
    13.7 (11.0 to 16.3)
    13.7 (11.0 to 16.3)
    Statistical analysis title
    		 Primary Endpoint – Change in IOP from Baseline
    Statistical analysis description
    As recruitment was not met for this study, our analysis were performed by pooling the groups to the following: Patients with atopic dermatitis treated with Hydrocortison 1%/Hydrocortison-17-butyrat 0.1% Healthy treated controls treated with Hydrocortison 1%/Hydrocortison-17-butyrat 0.1% Healthy untreated controls with no intervention. Treatment difference in change from baseline in patients with atopic dermatitis and healthy treated controls compared to healthy untreated controls
    Comparison groups
    Hydrocortisone cream 1% (AD) v Hydrocortison-17-butyrat 0.1% (AD) v Control v Hydrocortisone cream 1% (Healthy) v Hydrocortison-17-butyrat 0.1% (Healthy)
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05 [2]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - Changes in outcome between baseline and study days and estimated treatment difference were analyzed using a constrained linear mixed model with inherent baseline adjustment. An unstructured covariance was assumed to account for repeated measurements on study participants. Results were reported as baseline mean and mean differences with 95% CI for approximately normally distributed outcomes. Goodness of fit was assessed by residual diagnostics. Analyses were performed using SAS Enterprise.
    [2] - Changes in outcome between baseline and study days and estimated treatment difference were analyzed using a constrained linear mixed model with inherent baseline adjustment. An unstructured covariance was assumed to account for repeated measurements.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    October 2021 to August 2023
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Hydrocortison-17-butyrat 0.1% (AD)
    Reporting group description
    		 -

    Serious adverse events
    		 Hydrocortison-17-butyrat 0.1% (AD)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Hydrocortison-17-butyrat 0.1% (AD)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    Infections and infestations
    Viral rhinitis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Recruitment for this study was not met due to substantial reluctance among potential participants. Participants were concerned about use of TCS around the eyes, particularly the potential risk of inducing glaucoma.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Aug 11 14:25:44 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA