Study Details

A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants with Lichen Sclerosus

(IRB#: IRB_00201682)

To participate in this study you must have mild to severe chronic inflammatory skin condition called lichen sclerosus (LS) affecting the area between and including the external genitals and anus (anogenital region). This study is made up of 2 parts. The purpose of Part 1 of this study is to investigate the safety and efficacy (how well it works) of a study cream called delgocitinib at 2 different doses by comparing it with a cream vehicle (placebo) for the treatment of LS in adults. Based on the results of Part 1, one of the doses will be further investigated in Part 2 of the study. The part 1 study is only available for female participants. In part 2, male and female participants may enroll. Delgocitinib (under the name Anzupgo®) is currently approved by the U.S. Food and Drug Adminstration (US FDA), the health authority in the U.S. for the treatment of moderate to severe chronic hand eczema in adults. Delgocitinib is considered an investigational product in this study because it has not been approved by U.S. FDA, for the treatment of LS. There are currently no approved specific treatments for LS. This study is the first time delgocitinib will be evaluated for the treatment of LS.

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