The Journal of investigative dermatology · 2025
Randomized Controlled Trial of the Topical Jak Inhibitor Delgocitinib Cream in Patients with Frontal Fibrosing Alopecia.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Martin Aubrey, Shokrian Neda, Kelley Kristen J, Correa da Rosa Joel, Del-Duca Ester, Bissonnette Robert, Sørensen Ole E, Nielsen Anders Bacher, Guttman-Yassky Emma, Senna Maryanne Makredes
Аннотация
BACKGROUND: Frontal fibrosing alopecia (FFA) is a cicatricial alopecia with generally poor prognosis if untreated and no approved treatment options.
OBJECTIVE: The aim of this study was to evaluate changes in the molecular signature of FFA lesions after application of delgocitinib cream. Safety, tolerability, and efficacy were also investigated.
METHODS: This was a phase 2a, randomized, double-blind, exploratory trial of 20 mg/g delgocitinib cream (2%) versus cream vehicle in patients with FFA.
RESULTS: A total of 30 adult females with FFA were randomized to delgocitinib cream (n = 15) or cream vehicle (n = 15). After 12 weeks, expression of the T helper 1-related biomarker CXCL9 was significantly downregulated (-3.10; P < .05), whereas there were nonsignificant reductions in CXCL10 (-2.60; P < .1) and IFN-γ (-1.49; P = .22) in lesions treated with delgocitinib cream but not cream vehicle. Delgocitinib-treated lesions had a small but significant mean improvement in transcriptomic profile (4%; P < .001), whereas lesions treated with cream vehicle worsened (33%). Delgocitinib cream was well-tolerated and associated with improvements in exploratory clinical severity endpoints.
LIMITATIONS: Limitations of the trial include small sample size, biomarker analyses only being conducted to week 12, and the exploratory nature of efficacy endpoints.
CONCLUSION: Delgocitinib cream resulted in an improvement in the transcriptomic profile of lesions and may have potential as a topical treatment for FFA. This study is registered with NCT05332366.
OBJECTIVE: The aim of this study was to evaluate changes in the molecular signature of FFA lesions after application of delgocitinib cream. Safety, tolerability, and efficacy were also investigated.
METHODS: This was a phase 2a, randomized, double-blind, exploratory trial of 20 mg/g delgocitinib cream (2%) versus cream vehicle in patients with FFA.
RESULTS: A total of 30 adult females with FFA were randomized to delgocitinib cream (n = 15) or cream vehicle (n = 15). After 12 weeks, expression of the T helper 1-related biomarker CXCL9 was significantly downregulated (-3.10; P < .05), whereas there were nonsignificant reductions in CXCL10 (-2.60; P < .1) and IFN-γ (-1.49; P = .22) in lesions treated with delgocitinib cream but not cream vehicle. Delgocitinib-treated lesions had a small but significant mean improvement in transcriptomic profile (4%; P < .001), whereas lesions treated with cream vehicle worsened (33%). Delgocitinib cream was well-tolerated and associated with improvements in exploratory clinical severity endpoints.
LIMITATIONS: Limitations of the trial include small sample size, biomarker analyses only being conducted to week 12, and the exploratory nature of efficacy endpoints.
CONCLUSION: Delgocitinib cream resulted in an improvement in the transcriptomic profile of lesions and may have potential as a topical treatment for FFA. This study is registered with NCT05332366.