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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05355818
Registration number
NCT05355818
Ethics application status
Date submitted
27/04/2022
Date registered
2/05/2022
Date last updated
31/05/2024
Titles & IDs
Public title
Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
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Scientific title
A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
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Secondary ID [1]
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2021-006340-27
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Secondary ID [2]
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LP0133-1426
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Universal Trial Number (UTN)
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Trial acronym
DELTA TEEN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hand Eczema
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Condition category
Condition code
Skin
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Delgocitinib
Treatment: Drugs - Cream vehicle
Experimental: Delgocitinib cream - Delgocitinib cream 20 mg/g twice daily
Placebo Comparator: Cream vehicle - Cream vehicle twice daily
Treatment: Drugs: Delgocitinib
Cream for topical application
Treatment: Drugs: Cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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IGA-CHE treatment success at Week 16
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Assessment method [1]
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The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a =2 step improvement from baseline.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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HECSI-90 at Week 16
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Assessment method [1]
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The Hand Eczema Severity Index (HECSI) is a scoring system to rate the severity of hand eczema. It gives a score from 0 (none) to 3 (severe) to 6 clinical signs of hand eczema: erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema over 5 regions of the hand - fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists. Each region is then assigned an area score from 0 (0%) to 4 (>75%) depending on how much is covered by lesions. For each region a region score is calculated by adding up the severity scores for the 6 clinical signs and multiplying with the area score. The HESCI score equals the sum of the 5 region scores and ranges from 0 to 360. HECSI-90 is at least 90% improvement in HECSI score from baseline
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Reduction of HESD itch score (weekly average) of =4 points from baseline at Week 16
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Assessment method [2]
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The Hand Eczema Symptom Diary© (HESD) is an eDiary which patients use everyday to score the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours from 0 (none) to 10 (severe). This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of =4 points.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Reduction of HESD pain score (weekly average) of =4 points from baseline at Week 16
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Assessment method [3]
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The Hand Eczema Symptom Diary© (HESD) is an eDiary which patients use everyday to score the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours from 0 (none) to 10 (severe). This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of =4 points.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Reduction of HESD score (weekly average) of =4 points from baseline at Week 16
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Assessment method [4]
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The Hand Eczema Symptom Diary© (HESD) is an eDiary which patients use everyday to score the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours from 0 (none) to 10 (severe). The final HESD score is an average of these 6 individual scores. This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of =4 points.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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IGA-CHE treatment success at Week 2
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Assessment method [5]
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The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a =2 step improvement from baseline.
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Timepoint [5]
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Week 2
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Secondary outcome [6]
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IGA-CHE treatment success at Week 4
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Assessment method [6]
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The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a =2 step improvement from baseline.
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Timepoint [6]
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Week 4
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Secondary outcome [7]
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IGA-CHE treatment success at Week 8
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Assessment method [7]
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The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a =2 step improvement from baseline.
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Timepoint [7]
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Week 8
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Secondary outcome [8]
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IGA-CHE treatment success at Week 12
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Assessment method [8]
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The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a =2 step improvement from baseline.
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Timepoint [8]
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Week 12
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Secondary outcome [9]
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Change in cDLQI score from baseline to Week 16
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Assessment method [9]
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The children's Dermatology Life Quality Index (cDLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. Each question is scored from 0 (no impact) to 3 (high impact). The cDLQI score is the sum of the 10 items (score ranging from 0 to 30).
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Number of treatment emergent AEs from baseline up to Week 18
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Assessment method [10]
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An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment.
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Timepoint [10]
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Week 18
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Eligibility
Key inclusion criteria
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or
returned twice or more within the last 12 months.
- Disease severity graded as moderate to severe at screening and baseline according to
IGA-CHE.
- Subjects who have a documented history of inadequate response to treatment with TCS or
for whom TCS are documented to be otherwise medically inadvisable.
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Minimum age
12
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Concurrent skin disease on the hands.
- Clinically significant infection on the hands.
- Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or
corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or
intranasal steroids corresponding to up to 1 mg prednisolone for allergic
conjunctivitis, asthma, or rhinitis are allowed).
- Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior
to baseline.
- Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249),
systemic or topical.
- Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days
prior to baseline.
- Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14
days prior to baseline.
- Other cutaneously applied therapy on the hands (except for the use of subject's own
emollients) within 7 days prior to baseline.
- Cutaneously applied treatments in regions other than the hands, which could interfere
with clinical trial evaluations or pose a safety concern within 7 days prior to
baseline.
- Any disorder which is not stable and could:
- Affect the safety of the subject throughout the trial.
- Impede the subject's ability to complete the trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
17/12/2024
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Actual
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Sample size
Target
92
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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LEO Pharma investigational site - Darlinghurst
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Recruitment hospital [2]
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LEO Pharma investigational site - Mitcham
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Recruitment hospital [3]
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LEO Pharma investigational site - Phillip
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Recruitment hospital [4]
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LEO Pharma investigational site - Woolloongabba
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3132 - Mitcham
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Recruitment postcode(s) [3]
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2606 - Phillip
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Brussels
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Belgium
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Gent
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Belgium
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Liège
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Belgium
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Loverval
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Canada
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Fredericton
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Canada
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Kingston
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Canada
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Montreal
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Canada
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Red Deer
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Canada
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St. John's
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Canada
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Toronto
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Canada
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Winnipeg
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France
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Bouches-du-Rhône
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France
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Nice
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France
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Reims
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France
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Rouen
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France
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Toulouse Cedex 9
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Poland
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Chorzow
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Kraków
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Warszawa
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Wroclaw
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Alicante
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Spain
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Barcelona
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Spain
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Cadiz
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Spain
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Esplugues de Llobregat
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Spain
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Fuenlabrada
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Spain
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Granada
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Spain
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Pontevedra
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United Kingdom
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Ipswich
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United Kingdom
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King's Lynn
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Leytonstone
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United Kingdom
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Lincoln
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United Kingdom
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London
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United Kingdom
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Walsall
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
LEO Pharma
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to test if delgocitinib cream is effective at treating chronic
hand eczema (CHE) and what side effects it may have, in children aged 12-17. There will be a
range of assessments that rate the severity and extent of CHE symptoms, general health and
quality of life.
Delgocitinib is a cream that suppresses specific processes in the body's response to diseases
like CHE, such as inflammation.
The trial will last up to 22 weeks and has a 1-4 week screening period, a 16 week treatment
period and a 2 week follow up period. During the treatment period each child will use either
delgocitinib cream or a cream vehicle twice a day. Which cream each child receives is chosen
randomly by a computer. The cream vehicle is made of the same ingredients as the delgocitinib
cream except for the active medical ingredient. There will be 8 visits with the trial doctor.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05355818
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Expert
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Address
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LEO Pharma
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Phone
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Contact person for public queries
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Clinical Disclosure
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Address
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Phone
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(+1) 877-557-1168
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05355818
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