Cortisone treatment for children with facial nerve palsy
The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial
This study is testing if cortisone treatment can help children with facial nerve palsy recover better than those who receive a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Dalarna County Council, Sweden Academic / other |
| Locations | 15 sites (Falun, Dalarna County and 14 other locations) |
| Trial ID | NCT03781700 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of cortisone treatment in children diagnosed with acute facial nerve palsy, a condition that can lead to persistent symptoms such as facial asymmetry and social challenges. The study is a double-blind, randomized, placebo-controlled trial conducted across multiple centers in Sweden. Participants aged 1 to 17 years will receive either oral prednisolone or a placebo for 10 days, starting within 72 hours of symptom onset. The primary outcome will be assessed at 12 months using the House-Brackmann scale to measure recovery of facial nerve function.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-17 years with acute unilateral facial nerve palsy who have experienced symptoms for less than 72 hours.
Not a fit: Patients with central or bilateral facial nerve palsy, recent head trauma, or serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for children suffering from acute facial nerve palsy.
How similar studies have performed: Previous studies on cortisone treatment in adults have shown beneficial effects, but this approach in children is novel and has not been rigorously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Falun, Dalarna County and 14 other locations
- Barn- och ungdomsmedicin — Falun, Dalarna County, Sweden (Recruiting)
- Barn och ungdomskliniken, Länssjukhuset — Kalmar, Region Kalmar, Sweden (Recruiting)
- Barnkliniken, Skaraborgs sjukhus — Skövde, Västra Götalands Region, Sweden (Recruiting)
- Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset — Gothenburg, Sweden (Recruiting)
- Barn- och ungdomsmedicinska kliniken — Jönköping, Sweden (Recruiting)
- Barn- och ungdomsmottagning — Karlskrona, Sweden (Recruiting)
- HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus — Linköping, Sweden (Recruiting)
- Akutmottagning för barn, Skåne Universitets sjukhus — Lund, Sweden (Recruiting)
- Barnakuten i Malmö, Skåne Universitets sjukhus — Malmö, Sweden (Recruiting)
- Barn- och ungdomskliniken, Vrinnevi sjukhuset — Norrköping, Sweden (Recruiting)
- Barn- och ungdomskliniken, Universitets sjukhuset Örebro — Örebro, Sweden (Recruiting)
- Astrid Lindgrens barnsjukhus, Karolinska Solna — Solna, Sweden (Recruiting)
- Sachsska barnsjukhuset — Stockholm, Sweden (Recruiting)
- Astrid Lindgrens barnsjukhus, Karolinska Huddinge — Stockholm, Sweden (Recruiting)
- Akademisk Barnsjukhuset — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Barbro Hedin Skogman, MD, PhD
- Email: barbro.hedinskogman@regiondalarna.se
- Phone: +46 (0)23 49 20 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.