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Janus Kinase Inhibitor

Delgocitinib cream for 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
Awards & highlights

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
  • Frontal Fibrosing Alopecia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

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 2020 Phase 2 trial • 258 Patients • NCT03683719
17%
Nasopharyngitis
10%
Eczema
6%
Pruritus
6%
Toothache
4%
Headache
2%
Dermatitis atopic
2%
Influenza
2%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Delgocitinib Cream 1 mg/g
Delgocitinib Cream 3 mg/g
Delgocitinib Cream 8 mg/g
Delgocitinib Cream 20 mg/g
Delgocitinib Cream 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
270 Previous Clinical Trials
188,614 Total Patients Enrolled
Translational Medical LeaderStudy DirectorLEO Pharma
~10 spots leftby Sep 2025
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