Corticosteroid treatment for children with acute facial palsy (the FACE study) - a randomized double-blind placebo-controlled multicenter study

Background
Acute facial palsy is a dramatic symptom that affects 5–20 per 100,000 children per year. In approximately 20–30% of cases, children experience persistent symptoms such as excessive tear secretion, drooling, slurred speech, and noticeable facial asymmetry, which are perceived as both functionally and socially distressing. Adult patients with acute facial palsy are recommended corticosteroid treatment, based on large randomized controlled trials, to reduce the risk of long-term sequelae. High-quality studies regarding facial palsy in children are lacking.

Material and Methods
A double-blind randomized placebo-controlled multicenter study (the FACE study) investigating corticosteroids versus placebo for children with facial palsy was initiated in 2019 and is planned to be completed in 2026. The study involves 16 pediatric clinics in Sweden and has included a total of 338 patients. The children are followed for one year using scales measuring facial function and quality of life.

Aim
To investigate whether corticosteroids are beneficial for children with acute facial palsy in terms of symptom resolution.

Clinical Relevance
The study has high clinical relevance. If our study can demonstrate that corticosteroid treatment is well tolerated and leads to improved recovery in children with acute facial palsy, an estimated 50 children per year in Sweden may avoid long-term facial palsy. We will develop national and international guidelines.