Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05355818
Registration number
NCT05355818
Ethics application status
Date submitted
27/04/2022
Date registered
2/05/2022
Titles & IDs
Public title
Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
Query!
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
Query!
Secondary ID [1]
0
0
2021-006340-27
Query!
Secondary ID [2]
0
0
LP0133-1426
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
DELTA TEEN
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Hand Eczema
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
IGA-CHE treatment success at Week 16
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 16
Query!
Secondary outcome [1]
0
0
HECSI-90 at Week 16
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
Week 16
Query!
Secondary outcome [2]
0
0
Reduction of HESD itch score (weekly average) of =4 points from baseline at Week 16
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 16
Query!
Secondary outcome [3]
0
0
Reduction of HESD pain score (weekly average) of =4 points from baseline at Week 16
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Week 16
Query!
Secondary outcome [4]
0
0
Reduction of HESD score (weekly average) of =4 points from baseline at Week 16
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Week 16
Query!
Secondary outcome [5]
0
0
IGA-CHE treatment success at Week 2
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Week 2
Query!
Secondary outcome [6]
0
0
IGA-CHE treatment success at Week 4
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Week 4
Query!
Secondary outcome [7]
0
0
IGA-CHE treatment success at Week 8
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Week 8
Query!
Secondary outcome [8]
0
0
IGA-CHE treatment success at Week 12
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Week 12
Query!
Secondary outcome [9]
0
0
Change in cDLQI score from baseline to Week 16
Query!
Assessment method [9]
0
0
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).
Query!
Timepoint [9]
0
0
Week 16
Query!
Secondary outcome [10]
0
0
Number of treatment emergent AEs from baseline up to Week 18
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Week 18
Query!
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.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/07/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
17/12/2024
Query!
Actual
Query!
Sample size
Target
92
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
LEO Pharma investigational site - Darlinghurst
Query!
Recruitment hospital [2]
0
0
LEO Pharma investigational site - Mitcham
Query!
Recruitment hospital [3]
0
0
LEO Pharma investigational site - Phillip
Query!
Recruitment hospital [4]
0
0
LEO Pharma investigational site - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
3132 - Mitcham
Query!
Recruitment postcode(s) [3]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Brussels
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Gent
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Liège
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Loverval
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Edmonton
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Fredericton
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Kingston
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Montreal
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
Red Deer
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
St. John's
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Toronto
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Winnipeg
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Bouches-du-Rhône
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Nice
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Reims
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Rouen
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Toulouse Cedex 9
Query!
Country [18]
0
0
Poland
Query!
State/province [18]
0
0
Chorzow
Query!
Country [19]
0
0
Poland
Query!
State/province [19]
0
0
Kraków
Query!
Country [20]
0
0
Poland
Query!
State/province [20]
0
0
Warszawa
Query!
Country [21]
0
0
Poland
Query!
State/province [21]
0
0
Wroclaw
Query!
Country [22]
0
0
Spain
Query!
State/province [22]
0
0
Alicante
Query!
Country [23]
0
0
Spain
Query!
State/province [23]
0
0
Barcelona
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Cadiz
Query!
Country [25]
0
0
Spain
Query!
State/province [25]
0
0
Esplugues de Llobregat
Query!
Country [26]
0
0
Spain
Query!
State/province [26]
0
0
Fuenlabrada
Query!
Country [27]
0
0
Spain
Query!
State/province [27]
0
0
Granada
Query!
Country [28]
0
0
Spain
Query!
State/province [28]
0
0
Pontevedra
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
Ipswich
Query!
Country [30]
0
0
United Kingdom
Query!
State/province [30]
0
0
King's Lynn
Query!
Country [31]
0
0
United Kingdom
Query!
State/province [31]
0
0
Leytonstone
Query!
Country [32]
0
0
United Kingdom
Query!
State/province [32]
0
0
Lincoln
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
London
Query!
Country [34]
0
0
United Kingdom
Query!
State/province [34]
0
0
Walsall
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
LEO Pharma
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05355818
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Expert
Query!
Address
0
0
LEO Pharma
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Clinical Disclosure
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
(+1) 877-557-1168
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://leopharmatrials.com/for-researchers
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05355818