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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
Study Summary
This trial is investigating the effect of delgocitinib cream 2% on reversing frontal fibrosing alopecia, a disease that causes hair loss.
Eligible Conditions
- Frontal Fibrosing Alopecia
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Therapeutic procedure
Side effects data
From 2020 Phase 2 trial • 258 Patients • NCT0368371917%
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
268 Previous Clinical Trials
188,474 Total Patients Enrolled
Translational Medical LeaderStudy DirectorLEO Pharma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being accepted into this study?
"The clinical trial is currently recruiting patients, with 35 needed in total from a single site. The study was first posted on 4/19/2022 and updated two days later on 4/21/2022."
Answered by AI
Could you walk me through the possible side effects of Delgocitinib cream?
"Delgocitinib cream is currently in Phase 2 of clinical trials. There is data supporting safety, but not yet efficacy. Therefore, it received a score of 2."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
LEO Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been suffering hair loss for a little over 2 years now. I’ve always had thin blonde hair and always wished for thicker hair especially in high school. Now at 65 I would simply kill for that same amount of hair. I would be thrilled to have only that much. My hair is changing who I am even though my brain knows I should not allow this. Hair to a woman is everything when you don’t have any or simply don’t have enough. Please consider me. I’m at a point in my life where I’m able to enjoy my adult daughters and my only grandchild and I am always wearing a baseball cap. The caps work until there is a nice event or dinner to attend. Please consider me.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
When or if I report to Burlington what will take place on that day ??
PatientReceived 1 prior treatment
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