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

August 31, 2026 updated by: Barbro Hedin Skogman, Dalarna County Council, Sweden

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset
      • Jönköping, Sweden, 55185
        • Barn- och ungdomsmedicinska kliniken
      • Karlskrona, Sweden, 37185
        • Barn- och ungdomsmottagning
      • Linköping, Sweden, 58585
        • HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus
      • Lund, Sweden, 22185
        • Akutmottagning för barn, Skåne Universitets sjukhus
      • Malmö, Sweden, 20502
        • Barnakuten i Malmö, Skåne Universitets sjukhus
      • Norrköping, Sweden, S-601 82
        • Barn- och ungdomskliniken, Vrinnevi sjukhuset
      • Solna, Sweden, 71764
        • Astrid Lindgrens barnsjukhus, Karolinska Solna
      • Stockholm, Sweden, 11883
        • Sachsska barnsjukhuset
      • Stockholm, Sweden, 14186
        • Astrid Lindgrens barnsjukhus, Karolinska Huddinge
      • Uppsala, Sweden, 75185
        • Akademisk Barnsjukhuset
      • Örebro, Sweden, S-70185
        • Barn- och ungdomskliniken, Universitets sjukhuset Örebro
    • Dalarna County
      • Falun, Dalarna County, Sweden, 79131
        • Barn- och ungdomsmedicin
    • Region Kalmar
      • Kalmar, Region Kalmar, Sweden, S-391 85
        • Barn och ungdomskliniken, Länssjukhuset
    • Västra Götalands Region
      • Skövde, Västra Götalands Region, Sweden, S-541 85
        • Barnkliniken, Skaraborgs sjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: At 12 months (+/- 2 weeks) after inclusion

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
Time Frame: At 12 months (+/- 2 weeks) after inclusion

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)
Time Frame: At 12 months (+/- 2 weeks) after inclusion
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
Time Frame: At 12 months (+/- 2 weeks) after inclusion
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)
Time Frame: At 12 month (+/- 2 weeks) after inclusion
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
Time Frame: Up to 12 month (+/- 2 weeks) after inclusion
Number of Adverse Events possibly or probably related to the study drug.
Up to 12 month (+/- 2 weeks) after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2019

Primary Completion (Actual)

August 31, 2026

Study Completion (Actual)

August 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)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FACE-01
  • 2017 (U.S. NIH Grant/Contract)
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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