This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational study drug to learn whether the delgocitinib 20 mg/g cream works in treating a specific disease. "Investigational" means that the delgocitinib 20 mg/g cream is being studied.
Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any trial-related procedures.
Subjects must be willing to comply with all trial procedures and must be available for the duration of the trial.
Male or female subject aged 18 years of age or older at the time of consent.
Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.
Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
Subject has had excessive sun exposure or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the trial. Use of sunscreen products (except on treated areas for subjects in Cohort 1) and protective apparel are recommended when sun exposure cannot be avoided.
Single group
Delgocitinib
DrugEveryone in this study receives the study drug (delgocitinib)
Hairline measurements
Change in hairline measurements from baseline to Week 24. (ie, lateral canthus \[right and left\] to hairline, lower glabellar crease to hair line, top of frontalis muscle to hair line, and mid brow to hair line \[right and left\])
Frontal scalp haircounts
Change in frontal scalp hair counts in a tattooed target area by trichoscopy from baseline to Week 24 following topical application of delgocitinib cream 20 mg/g in subjects with FFA.
Click on the lead sponsor to view all of their trials.
Maryanne Makredes Senna
Lead sponsor
Lahey Clinic
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
