Randomized Controlled Trial of the Topical Jak Inhibitor Delgocitinib Cream in Patients with Frontal Fibrosing Alopecia.

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.