Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children
NCT ID: NCT03826901
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2019-02-20
2021-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1: adults and adolescents (12 years and above)
Delgocitinib cream (dosage: A mg/g).
delgocitinib
Cream for topical application
Part 2: children (2-11 years)
Delgocitinib cream (dosage: B mg/g).
delgocitinib
Cream for topical application
Interventions
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delgocitinib
Cream for topical application
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 12 years and above at baseline
* AD involvement of 25-50% treatable body surface area (BSA) at screening and at baseline
* Moderate to severe AD (Validated Investigator Global Assessment scale for Atopic Dermatitis \[vIGA-AD\] score of at least 3) at screening and at baseline
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
* Age 2-11 years at baseline
* History of AD for at least 3 months (children aged 2-5 years), and at least 12 months (children aged 6-11 years)
* AD involvement of ≥35% treatable BSA at screening and at baseline
* Moderate to severe AD (vIGA-AD score of at least 3) at screening and at baseline
Exclusion Criteria
* Use of tanning beds or phototherapy within 4 weeks prior to baseline
* Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline
* Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), topical phosphodiesterase-4, or oral antibiotics within 1 week prior to baseline
* Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline
* Any disorder, which is not stable, and in the investigator's opinion could affect the safety of the subject, influence the results of the trial or impede the subject's ability to complete the trial
2 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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LEO Pharma investigational site
Birmingham, Alabama, United States
LEO Pharma investigational site
Phoenix, Arizona, United States
LEO Pharma investigational site
Fountain Valley, California, United States
LEO Pharma investigational site
Irvine, California, United States
LEO Pharma investigational site
Los Angeles, California, United States
LEO Pharma investigational site
Centennial, Colorado, United States
LEO Pharma investigational site
New Haven, Connecticut, United States
LEO Pharma investigational site
Indianapolis, Indiana, United States
LEO Pharma investigational site
Ypsilanti, Michigan, United States
LEO Pharma investigational site
Tulsa, Oklahoma, United States
LEO Pharma investigational site
Medford, Oregon, United States
LEO Pharma investigational site
San Antonio, Texas, United States
LEO Pharma investigational site
Red Deer, Alberta, Canada
LEO Pharma investigational site
Hamilton, Ontario, Canada
LEO Pharma investigational site
Montreal, Quebec, Canada
LEO Pharma investigational site
Montreal, Quebec, Canada
Countries
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Other Identifiers
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LP0133-1181
Identifier Type: -
Identifier Source: org_study_id
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