This study evaluates the safety, tolerability, and biomarker effects of twice-daily topical delgocitinib 2% cream in adults with lichen planopilaris (LPP) or central centrifugal cicatricial alopecia (CCCA) over a 48-week treatment period. Approximately 30 participants will be enrolled: 15 CCCA and 15 LPP. The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS).
Participants of any gender, age 18 years or older, at the time of informed consent at Screening.
Participants who are willing and able to adhere to the study visit schedule and comply with protocol requirements.
Participant self-reports a history of at least 6 months of CA (LPP or CCCA). Diagnosis will be made clinically (according to the LPPAI10, and/or CHLG11) and/or histopathologically.
Participants who are females of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 28 days after the last dose of study drug. Acceptable methods of birth control include intrauterine device (IUD) oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence; barrier methods with spermicide. If not of child-bearing potential, Participants must have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
Participants of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
Participant has a history of CA for ≥ 4 years since the disease onset, severe fibrosing disease, or very rapid hair loss at screening.
Participant has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening.
Other scalp disease that may impact assessment (e.g., scalp psoriasis, dermatitis, etc.).
Parallel
Delgocitinib
Drugtwice-daily topical 2% cream
Changes in IFNγ in CA scalp in delgocitinib-treated patients
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes in CCL5 in CA scalp in delgocitinib-treated patients
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes CXCL9 markers in CA scalp in delgocitinib-treated patients
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes in CXCL10 in CA scalp in delgocitinib-treated patients
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes in IFNγ in CA scalp in delgocitinib-treated patients
Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48
Changes in CCL5 in CA scalp in delgocitinib-treated patients
Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48
Changes in CXCL9 in CA scalp in delgocitinib-treated patients
Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48
Changes in Th1 markersCXCL10in CA scalp in delgocitinib-treated patients
Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48
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Icahn School of Medicine at Mount Sinai
Lead sponsor
LEO Pharma
Collaborator
