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NCT Number: NCT03781700

Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

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.

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Key information

Conditions

Facial Palsy Bell Palsy Borrelia Infection of Central Nervous System Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Facial Paralysis Herpesviridae Infections Infections Mouth Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Virus Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barn- och ungdomsmedicin, Falun, Dalarna County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1-17 years of age
  • 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 (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
  • 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 onset of symptoms
  • Immunization with live vaccine 1 month prior 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

Treatment and study plan

Prednisolone

Drug

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

Placebo oral tablet

Drug

Placebo tablets with identical appearance to the experimental drug

Other names: Batch 18A61, Orifarm Generics A/S

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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).

  4. 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).

Other outcomes

  1. Adverse events

    Time frame: Up to 12 month (+/- 2 weeks) after inclusion

    Number of Adverse Events possibly or probably related to the study drug.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbro Hedin Skogman, MD, PhD

CONTACT

[email protected]

+46 (0)23 49 20 00

Sofia Karlsson, MD

CONTACT

[email protected]

+46 (0)23 49 20 00

Sponsors and collaborators

Lead sponsor

Dalarna County Council, Sweden

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: FACE

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2018
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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