biostudies-literatureUnknown22(1)Skullerud KHCelgeneAmgenOslo University Hospital<h4>Background</h4>Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal erosions and scarring, often resulting in poor sexual health and reduced quality of life. Treatment options are limited and often with little effect. Apremilast, a phosphodiesterase 4-inhibitor, has been shown to have a positive effect on psoriasis and other inflammatory skin diseases. We aim to investigate the effect and safety of peroral apremilast in women with GELP in a randomised placebo-controlled double-blinded clinical trial.<h4>Methods</h4>We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a Trials469https://www.ebi.ac.uk/biostudies/studies/S-EPMC8290211biostudies-literatureApremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial.PMC8290211Gjersvik PHelgesen ALOSkullerud KHPripp AHQvigstad EfalseApremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial.<h4>Background</h4>Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal erosions and scarring, often resulting in poor sexual health and reduced quality of life. Treatment options are limited and often with little effect. Apremilast, a phosphodiesterase 4-inhibitor, has been shown to have a positive effect on psoriasis and other inflammatory skin diseases. We aim to investigate the effect and safety of peroral apremilast in women with GELP in a randomised placebo-controlled double-blinded clinical trial.<h4>Methods</h4>We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a 2021-01-01T00:00:00Z2021 Jul2026-05-07T19:54:26.981Z2022-02-10T22:05:07.753ZS-EPMC82902113428480810.1186/s13063-021-05428-w