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Janus Kinase Inhibitor
A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
Phase 2
Waitlist Available
Research Sponsored by LEO Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Summary
This trial is testing a skin cream called delgocitinib on people with frontal fibrosing alopecia (FFA), a type of hair loss. The cream aims to reduce skin inflammation and immune responses to help stop or reverse hair loss.
Eligible Conditions
- Hair Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in expression of chemokine (C-X-C motif) ligand 9 (CXCL9), chemokine (C-X-C motif) ligand 10 (CXCL10), and interferon (IFN)-γ from baseline to Week 12.
Side effects data
From 2022 Phase 3 trial • 487 Patients • NCT0487171111%
COVID-19
7%
Nasopharyngitis
3%
Headache
2%
Allergy to metals
1%
Dermatitis contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
Delgocitinib |20 mg/g
Vehicle|
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Delgocitinib - DelgocitinibExperimental Treatment1 Intervention
Participants will be blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Group II: No treatmentActive Control1 Intervention
Participants will not receive any treatment. They will only provide a molecular signature of healthy skin to act as a control.
Group III: Placebo - DelgocitinibPlacebo Group2 Interventions
Participants will be blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Delgocitinib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
LEO PharmaLead Sponsor
271 Previous Clinical Trials
188,838 Total Patients Enrolled
Translational Medical LeaderStudy DirectorLEO Pharma