NCT03781700.

Trial name or title	Evaluation of cortisone treatment in children with acute facial nerve palsy (FACE)
Methods	Randomised, parallel assignment, quadruple‐blind (participant, care provider, investigator, outcome assessor), phase IV RCT
Participants	Children with acute peripheral unilateral facial palsy Inclusion criteria 1 to 17 years old Acute peripheral unilateral facial nerve palsy Less than 72 hours since debut of symptoms Signed informed consent Exclusion criteria Head trauma < 1 month Central or bilateral facial nerve palsy Malformations in head and neck Conditions not compatible with cortisone treatment Current or past oncological diagnosis Other serious medical conditions (meningitis, encephalitis, stroke) Acute otitis media Signs of herpes simplex or varicella zoster infection (vesicles in the ear region) Pregnancy or breastfeeding Use of any systemic or inhaled steroids within 2 weeks prior to onset of symptoms Immunisation with live vaccine 1 month prior to onset of symptoms Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo) Evaluation of primary endpoint at 12 months not feasible for any reason Previously included into the FACE study
Interventions	Prednisolone 5 mg tablets, 1 mg/kg bodyweight orally per day for 10 days, maximum 50 mg per day Placebo: oral tablet identical in appearance
Outcomes	Primary outcomes Total recovery assessed on the House‐Brackmann scale at 12 months (+/‐ 2 weeks) after inclusion (a scale where I is normal function and VI is total loss of function) Secondary outcomes Total recovery assessed on the Sunnybrook Facial Grading System (Ross 1996) at 12 months (+/‐ 2 weeks) after inclusion (a scale where 100 is normal function and 0 is total loss of function) Facial Disability Index (FDI) at 12 months (+/‐ 2 weeks) after inclusion (a scale with 5 functional domains: 5 means no problems and 2 or 1 means problems all the time; and 5 social domains: 6 means problems all the time and 1 means no problems at all) Facial Clinimetric Evaluation (FaCE) Scale at 12 months (+/‐ 2 weeks) after inclusion (a scale with 15 functional and social domains: 1 means problems all the time and 5 means no problems at all) Synkinesis Assessment Questionnaire (SAQ) at 12 months (+/‐ 2 weeks) after inclusion. This is subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time) Adverse events at 12 months (+/‐ 2 weeks) after inclusion, assessed as number of adverse events possibly or probably related to the study drug
Starting date	3 May 2019
Contact information	Barbro Hedin Skogman: barbro.hedinskogman@ltdalarna.se, Center for Clinical Research Dalarna, Sweden
Notes	Sweden