Facial PalsyPhase 4FACENCT03781700
Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
A Phase 4 study testing Prednisolone in people with Facial Palsy and Facial Nerve Diseases, run by Dalarna County Council, Sweden at 15 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Facial Palsy, Facial Nerve Diseases, Borrelia Infection of Central Nervous System
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 343 participants
- Where
- 15 sitesSweden
- Study dates
- 3 May 2019to 31 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-17 years of age
- Acute peripheral unilateral facial nerve palsy
- Less than 72 hours since debut of symptoms
- Signed informed consent
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Sweden15 sites
Barn- och ungdomsmedicin
Falun, Dalarna County, 79131
Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset
Gothenburg
Barn- och ungdomsmedicinska kliniken
Jönköping, 55185
Barn och ungdomskliniken, Länssjukhuset
Kalmar, Region Kalmar, S-391 85
Barn- och ungdomsmottagning
Karlskrona, 37185
HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus
Linköping, 58585
Akutmottagning för barn, Skåne Universitets sjukhus
Lund, 22185
Barnakuten i Malmö, Skåne Universitets sjukhus
Malmö, 20502
Barn- och ungdomskliniken, Vrinnevi sjukhuset
Norrköping, S-601 82
Barn- och ungdomskliniken, Universitets sjukhuset Örebro
Örebro, S-70185
Barnkliniken, Skaraborgs sjukhus
Skövde, Västra Götalands Region, S-541 85
Astrid Lindgrens barnsjukhus, Karolinska Solna
Solna, 71764
Sachsska barnsjukhuset
Stockholm, 11883
Astrid Lindgrens barnsjukhus, Karolinska Huddinge
Stockholm, 14186
Akademisk Barnsjukhuset
Uppsala, 75185
About this study
Official title: 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.
Read more
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.
- Conditions
- Facial Palsy, Facial Nerve Diseases, Borrelia Infection of Central Nervous System, Bell Palsy
- Being tested
- Prednisolone, Placebo Oral Tablet
- Keywords
- Children, Paediatric
- Medical subject headings
- Facial Paralysis, Facial Nerve Diseases, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called Batch 18A71, Orifarm Generics A/S
Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
Placebo Oral TabletDrug
Also called Batch 18A61, Orifarm Generics A/S
Placebo tablets with identical appearance to the experimental drug
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Experimental | Prednisolone Receives: Drug: Prednisolone |
| Placebo | Placebo comparator | Placebo oral tablet Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months (+/- 2 weeks) after inclusion
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: At 12 month (+/- 2 weeks) after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start3 May 2019
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Barbro Hedin Skogman, Dalarna County Council, Sweden
- Investigators
- Barbro Hedin Skogman, MD, PhD, Study director, Center for Clinical Research Dalarna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781700
- Sponsor's protocol ID
- FACE-01
- Other IDs
- 2017-004187-35, 2017
- Acronym
- FACE
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2018
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33947355
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT03781700
- Acronym / sponsor ID
- FACE / FACE-01
- Conditions
- Facial Palsy, Facial Nerve Diseases, Borrelia Infection of Central Nervous System, Bell Palsy
- Keywords
- Children, Paediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 3 May 2019 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Experimental | Drug: PrednisolonePrednisolone |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo oral tablet |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1-17 years of age
- Acute peripheral unilateral facial nerve palsy
- Less than 72 hours since debut of symptoms
- Signed informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneAlso: Batch 18A71, Orifarm Generics A/SPrednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day. | Drug | Prednisolone |
| Placebo Oral TabletAlso: Batch 18A61, Orifarm Generics A/SPlacebo tablets with identical appearance to the experimental drug | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Sunnybrook facial grading system
Time frame: At 12 months (+/- 2 weeks) after inclusion
Facial Disability Index (FDI)
Time frame: At 12 months (+/- 2 weeks) after inclusion
Facial Clinimetric Evaluation (FaCE) Scale
Time frame: At 12 months (+/- 2 weeks) after inclusion
Synkinesis Assessment Questionnaire (SAQ)
Time frame: At 12 month (+/- 2 weeks) after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 33947355Karlsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbro Hedin Skogman, MD, PhD study director
Center for Clinical Research Dalarna
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone in people with Facial Palsy and Facial Nerve Diseases, run by Dalarna County Council, Sweden at 15 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House-Brackmann scale (time frame: At 12 months (+/- 2 weeks) after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03781700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.