Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy (FACE)

The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial

Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in children.

Investigators will perform a double-blind randomized placebo-controlled multicenter trial on children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12 study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10 days (or placebo) will be started on admission. Clinical data, including recovery will be followed-up until 12 months.

The primary outcome is defined as total recovery of the facial nerve palsy, measured with the House-Brackmann scale (grade 1) at 12-months follow-up.

The overall purpose is to assess the utility of cortisone treatment given to children with acute facial nerve palsy in this study. If the total recovery rate is significantly improved in the prednisolone group as compared to the placebo group, prednisolone treatment will be introduced in clinical practice for children with acute facial nerve palsy in order to reduce the risk of persistent symptoms.

Study Overview

• Status: Recruiting
• Conditions: Facial Nerve Diseases; Facial Palsy; Bell Palsy; Borrelia Infection of Central Nervous System
• Intervention / Treatment: Drug: Prednisolone; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Barbro Hedin Skogman, MD, PhD; Phone Number: +46 (0)23 49 20 00; Email: barbro.hedinskogman@regiondalarna.se
• Study Contact Backup: Name: Sofia Karlsson, MD; Phone Number: +46 (0)23 49 20 00; Email: sofia.a.karlsson@regiondalarna.se

Study Locations

• Sweden
  • Göteborg, Sweden
    • Recruiting
    • Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset
    • Contact: Katarina Adrian
    • Principal Investigator: Katarina Adrian
  • Jönköping, Sweden, 55185
    • Recruiting
    • Barn- och ungdomsmedicinska kliniken
    • Contact: Thea Hamell; Phone Number: +46(0)10-2422000; Email: Thea.Hamell@rjl.se
    • Principal Investigator: Thea Hamell
  • Karlskrona, Sweden, 37185
    • Recruiting
    • Barn- och ungdomsmottagning
    • Contact: Mia Olsson Engman; Phone Number: +46(0)455-734253; Email: Mia.Engman@regionblekinge.se
    • Principal Investigator: Mia Olsson Engman
  • Linköping, Sweden, 58585
    • Recruiting
    • HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus
    • Contact: Peter Wide; Phone Number: +46(0)10-1030000; Email: Peter.Wide@regionostergotland.se
    • Principal Investigator: Peter Wide
  • Lund, Sweden, 22185
    • Recruiting
    • Akutmottagning för barn, Skåne Universitets sjukhus
    • Contact: Karin Stålhammar; Phone Number: +46(0)46-17 10 00; Email: Karin.Stalhammar@skane.se
    • Principal Investigator: Karin Stålhammar
  • Malmö, Sweden, 20502
    • Recruiting
    • Barnakuten i Malmö, Skåne Universitets sjukhus
    • Contact: Anna Karlsson; Phone Number: +46(0)40-33 10 00; Email: Anna.v.Karlsson@skane.se
    • Principal Investigator: Anna Karlsson
  • Norrköping, Sweden, S-601 82
    • Recruiting
    • Barn- och ungdomskliniken, Vrinnevi sjukhuset
    • Contact: Maria Nordwall; Phone Number: +46(0)10-103 00 00; Email: Maria.Nordvall@regionostergotland.se
    • Principal Investigator: Maria Nordwall
  • Solna, Sweden, 71764
    • Recruiting
    • Astrid Lindgrens barnsjukhus, Karolinska Solna
    • Contact: Sigurdur Arnason; Phone Number: +46(0)8-517 700 00; Email: sigurdur.arnason@sll.se
    • Principal Investigator: Sigurdur Arnason
  • Stockholm, Sweden, 11883
    • Recruiting
    • Sachsska barnsjukhuset
    • Contact: Charlotta Nordenhäll; Phone Number: +46(0)8-616 40 00; Email: charlotta.nordenhall@sll.se
    • Principal Investigator: Charlotta Nordenhäll
  • Stockholm, Sweden, 14186
    • Recruiting
    • Astrid Lindgrens barnsjukhus, Karolinska Huddinge
    • Contact: Åsa Fowler; Phone Number: +46(0)8-585 800 00; Email: asa.fowler@sll.se
    • Principal Investigator: Åsa Fowler
  • Uppsala, Sweden, 75185
    • Recruiting
    • Akademisk Barnsjukhuset
    • Contact: Åsa Laestadius; Phone Number: +46(0)18-611 00 00
    • Principal Investigator: Åsa Laestadius
  • Örebro, Sweden, S-70185
    • Recruiting
    • Barn- och ungdomskliniken, Universitets sjukhuset Örebro
    • Contact: Nisse Sandlund; Phone Number: +46(0)19-602 10 00; Email: nisse.sandlund@regionorebrolan.se
    • Principal Investigator: Nisse Sandlund
  • Dalarna
    • Falun, Dalarna, Sweden, 79131
      • Recruiting
      • Barn- och ungdomsmedicin
      • Contact: Barbro Hedin Skogman; Phone Number: +46 (0)23 49 20 00; Email: barbro.hedinskogman@regiondalarna.se
      • Principal Investigator: Barbro Hedin Skogman
  • Region Kalmar
    • Kalmar, Region Kalmar, Sweden, S-391 85
      • Recruiting
      • Barn och ungdomskliniken, Länssjukhuset
      • Contact: Anna Röcknert Tjernberg, PhD; Phone Number: +46(0)70-2370430; Email: anna.rockert@regionkalmar.se
      • Principal Investigator: Anna Röcknert Tjernberg, PhD
  • Västra Götalands Region
    • Skövde, Västra Götalands Region, Sweden, S-541 85
      • Recruiting
      • Barnkliniken, Skaraborgs sjukhus
      • Contact: Carl Johan Törnhage, PhD; Phone Number: +46(0)76 250 76 15; Email: carl-johan.tornhage@vgregion.se
      • Principal Investigator: Carl Johan Törnhage, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 1-17 years of age
2. Acute peripheral unilateral facial nerve palsy
3. Less than 72 hours since debut of symptoms
4. Signed informed consent

Exclusion Criteria:

1. Head trauma <1 month
2. Central or bilateral facial nerve palsy
3. Malformations in head and neck
4. Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
5. Current or past oncological diagnosis
6. Other serious medical conditions (meningitis, encephalitis, stroke)
7. Acute otitis media
8. Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)
9. Pregnancy or breastfeeding
10. Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
11. Immunization with live vaccine 1 month prior onset of symptoms
12. Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
13. Evaluation of primary endpoint at 12 months not feasible for any reason
14. Previously included into the FACE study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo oral tablet	Drug: Placebo Oral Tablet; Placebo tablets with identical appearance to the experimental drug; Other Names: Batch 18A61, Orifarm Generics A/S
Experimental: Prednisolone	Drug: Prednisolone; Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.; Other Names: Batch 18A71, Orifarm Generics A/S

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
House-Brackmann scale	Total recovery in the two treatment groups measured with the House-Brackmann scale. The House-Brackmann scale (I is normal function and VI is total loss of function) is chosen as primary outcome measure since it is an objective instrument, easy to perform and the one most frequently used in previous studies. The time point 12 months for evaluation of total recovery is chosen as no further improvement of the facial nerve function is expected after 12 months.	At 12 months (+/- 2 weeks) after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sunnybrook facial grading system	Total recovery in the two treatment groups measured with the Sunnybrook scale. The Sunnybrook scale (100 is normal function and 0 is total loss of function) is another objective scale for grading the facial nerve function. It will be used as secondary outcome measure. It is easy to perform and has been used in previous studies in children. It correlates well to the House-Brackmann scale.	At 12 months (+/- 2 weeks) after inclusion
Facial Disability Index (FDI)	Disease-specific Quality-of-Life assessment scale, with 5 functional domains (5 means no probelms 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)	At 12 months (+/- 2 weeks) after inclusion
Facial Clinimetric Evaluation (FaCE) Scale	Disease-specific Quality-of-Life assessment scale, with 15 functional and social domains (1 means problems all the time and 5 means no problems at all).	At 12 months (+/- 2 weeks) after inclusion
Synkinesis Assessment Questionnaire (SAQ)	Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time).	At 12 month (+/- 2 weeks) after inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of Adverse Events possibly or probably related to the study drug.	Up to 12 month (+/- 2 weeks) after inclusion

Collaborators and Investigators

• Sponsor: Dalarna County Council, Sweden
• Collaborators: Karolinska Institutet
• Investigators: Study Director: Barbro Hedin Skogman, MD, PhD, Center for Clinical Research Dalarna

Publications and helpful links

General Publications

• Karlsson S, Arnason S, Hadziosmanovic N, Laestadius A, Hultcrantz M, Marsk E, Skogman BH. The facial nerve palsy and cortisone evaluation (FACE) study in children: protocol for a randomized, placebo-controlled, multicenter trial, in a Borrelia burgdorferi endemic area. BMC Pediatr. 2021 May 4;21(1):220. doi: 10.1186/s12887-021-02571-w.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Children; Paediatric
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; DNA Virus Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Herpesviridae Infections; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Facies; Bell Palsy; Facial Paralysis; Facial Nerve Diseases; Borrelia Infections; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: FACE-01; 2017-004187-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No