The AP-GELP study: Effects of treatment with apremilast in women with genital erosive lichen planus

Supervisors: Researcher Anne Lise Helgesen, Professor Petter Gjersvik, Professor Erik Qvigstad

Background

Genital erosive lichen planus (GELP) is a chronic, autoimmune and scarring disease of the abdomen. It usually affects women aged 50-60 and causes painful sores in the vulva and anatomical changes including adhesions of the vagina, with daily complaints, reduced quality of life and sexual function. There is little research on GELP and the treatment options are unsatisfactory. The project is a trial of a possible new treatment for the skin/mucosal disease genital erosive lichen planus and a survey of the quality of life and sexual function in these patients.

We will conduct a randomized, double-blind, placebo-controlled study to measure the efficacy and safety of treatment with apremilast in women with moderate to severe GELP. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor with an immunosuppressive effect that is used in psoriasis and psoriatic arthritis.

Goal statement

Measure the effect and side effects of apremilast in women with moderate to severe GELP
Measure quality of life and sexual function at GELP
Immunohistochemical measurements in tissue at GELP

Collaboration partners

National competence service for women's health, Department of Gynecology, Oslo University Hospital (Vulva Poliklinikken) Olafia Clinic, Oslo University Hospital, Amgen