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Efficacy of Guselkumab in Treating Hailey Hailey Disease
Sponsor: Yale University
Summary
Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters. Histopathological findings include epidermal hyperplasia, suprabasilar clefting, dyskeratosis and acantholysis of keratinocytes. A final diagnosis of HHD is usually confirmed based on clinical and histopathological findings in line with genetic testing. Several treatment options have been proposed for this chronic and disabling disorder, however, there is no reproducibly effective therapeutic for it. The primary objective is to evaluate the treatment response of guselkumab. Single-center, non-randomized, single-arm, open-label, phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD.
Official title: Efficacy of Guselkumab in the Treatment of Hailey Hailey Disease: An Open-label, Proof of Concept Study
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2025-03-13
Completion Date
2026-04
Last Updated
2025-12-04
Healthy Volunteers
Yes
Conditions
Interventions
Guselkumab
Subcutaneous injection of 100 mg at Weeks 0, 4, 12, and 20
Locations (1)
Church Street Research Unit, Yale Center for Clinical Investigation
New Haven, Connecticut, United States