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Cortisone may be key to children's facial palsy recovery

NCT ID NCT03781700

Disease control Sponsor: Dalarna County Council, Sweden Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether a 10-day course of cortisone (prednisolone) helps children aged 1 to 17 with acute facial palsy recover fully. About 343 children will receive either the drug or a placebo, and their facial function will be measured at 12 months. The goal is to see if cortisone reduces the risk of lasting symptoms like drooling and facial asymmetry.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prednisolone, a cortisone drug, given as tablets for 10 days
What this could lead to
If cortisone improves recovery, it could become a standard treatment for children with acute facial palsy, reducing lasting symptoms like drooling and facial asymmetry.
What could go wrong
This is a phase 4 trial, but results may not show a clear benefit over placebo. Cortisone can have side effects, and the study only includes children without conditions that rule out its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

343 people

The number who actually took part.

Started

May 2019

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Bell's palsy facial nerve disorder facial paralysis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bell palsy Borrelia infection of central nervous system Facial nerve diseases Facial palsy

Contacts and locations

Locations

  • Akademisk Barnsjukhuset

    Uppsala, 75185, Sweden

  • Akutmottagning för barn, Skåne Universitets sjukhus

    Lund, 22185, Sweden

  • Astrid Lindgrens barnsjukhus, Karolinska Huddinge

    Stockholm, 14186, Sweden

  • Astrid Lindgrens barnsjukhus, Karolinska Solna

    Solna, 71764, Sweden

  • Barn och ungdomskliniken, Länssjukhuset

    Kalmar, Region Kalmar, S-391 85, Sweden

  • Barn- och ungdomskliniken, Universitets sjukhuset Örebro

    Örebro, S-70185, Sweden

  • Barn- och ungdomskliniken, Vrinnevi sjukhuset

    Norrköping, S-601 82, Sweden

  • Barn- och ungdomsmedicin

    Falun, Dalarna County, 79131, Sweden

  • Barn- och ungdomsmedicinska kliniken

    Jönköping, 55185, Sweden

  • Barn- och ungdomsmottagning

    Karlskrona, 37185, Sweden

  • Barnakuten i Malmö, Skåne Universitets sjukhus

    Malmö, 20502, Sweden

  • Barnkliniken, Skaraborgs sjukhus

    Skövde, Västra Götalands Region, S-541 85, Sweden

  • Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset

    Gothenburg, Sweden

  • HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus

    Linköping, 58585, Sweden

  • Sachsska barnsjukhuset

    Stockholm, 11883, Sweden

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