Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial.

ABSTRACT:

Background

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.

Methods

We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a

SUBMITTER: Skullerud KH 

PROVIDER: S-EPMC8290211 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature