ClinicalTrials.gg
Not yet recruitingNCT06213415Updated Jan 19, 2024

Role of Oral Steroid Alone Versus Oral Steroid Plus Intratympanic Steroid Injection in Bell's Palsy

An interventional study of Corticosteroid in Bell Palsy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

intratympanic steroid injection bell's palsy

Read the detailed description

Role of oral steroid alone versus oral steroid plus intratympanic steroid injection in Bell's palsy

02

Conditions studied

  • Bell Palsy

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03

In context

Bell Palsy

85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.

This study's planned enrollment of 42 is close to the median of 42 across 70 interventional studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mean Aged 18 years or more.

    • Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less.
    • Moderate to severe facial palsy [House-Brackmann grade IV or greater]

Exclusion criteria

Exclusion Criteria:

  • Another cause of facial nerve paralysis that is not idiopathic.

    • Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome.
    • Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose therapy.
    • Pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    Oral steroids

    Oral steroids only

    Drug: Corticosteroid

  • Active comparator
    Oral steroids plus intratympanic injections

    Oral steroids plus intratympanic injections

    Drug: Corticosteroid

Interventions

  • DrugCorticosteroid

    Oral steroids plus intratympanic injection

06

What researchers measure

Primary outcomes

  1. Success or failure of procedure to treat Bell's palsy

    Degree of regaining function to facial nerve Unit of measurement : nerve conduction study Measurement tool :endoscopic injection by ear microscope

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Agostini F, Mangone M, Santilli V, Paoloni M, Bernetti A, Saggini R, Paolucci T. Idiopathic facial palsy: umbrella review of systematic reviews and meta-analyses. J Biol Regul Homeost Agents. 2020 Jul-Aug;34(4):1245-1255. doi: 10.23812/20-339-A. PubMed 32935528 ↗
  • Chang CWD, McCoul ED, Briggs SE, Guardiani EA, Durand ML, Hadlock TA, Hillel AT, Kattar N, Openshaw PJM, Osazuwa-Peters N, Poetker DM, Shin JJ, Chandrasekhar SS, Bradford CR, Brenner MJ. Corticosteroid Use in Otolaryngology: Current Considerations During the COVID-19 Era. Otolaryngol Head Neck Surg. 2022 Nov;167(5):803-820. doi: 10.1177/01945998211064275. Epub 2021 Dec 7. PubMed 34874793 ↗
  • Hernandez-Trejo AF, Cuellar-Calderon KP, Trevino-Gonzalez JL, Yamamoto-Ramos M, Campos-Coy MA, Quiroga-Garza A, Guzman-Avilan K, Elizondo-Riojas G, Elizondo-Omana RE, Guzman-Lopez S. Prevalence of facial canal dehiscence and other bone defects by computed tomography. Eur Arch Otorhinolaryngol. 2020 Oct;277(10):2681-2686. doi: 10.1007/s00405-020-06013-8. Epub 2020 May 7. PubMed 32383094 ↗
  • Inagaki A, Minakata T, Katsumi S, Murakami S. Concurrent Treatment With Intratympanic Dexamethasone for Moderate-Severe Through Severe Bell's Palsy. Otol Neurotol. 2019 Dec;40(10):e1018-e1023. doi: 10.1097/MAO.0000000000002377. PubMed 31469789 ↗
  • Volk GF, Schaede RA, Thielker J, Modersohn L, Mothes O, Nduka CC, Barth JM, Denzler J, Guntinas-Lichius O. Reliability of grading of facial palsy using a video tutorial with synchronous video recording. Laryngoscope. 2019 Oct;129(10):2274-2279. doi: 10.1002/lary.27739. Epub 2018 Dec 20. PubMed 30570149 ↗
  • Walker NR, Mistry RK, Mazzoni T. Facial Nerve Palsy. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK549815/ PubMed 31747222 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2024; primary completion for Apr 2025, 14 months later.

Of 38 non-industry interventional studies with no phase under Bell Palsy, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 14 months is above that.

Counting every sponsor, half of 40 studies reached it within 10 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2023
First posted
Jan 19, 2024
StartEst.
Feb 2024
Primary completionEst.
Apr 2025
CompletionEst.
Nov 2026
Last update
Jan 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06213415
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Alaa Abd-Alraheem (Resident doctor, Assiut University) — Principal investigator
First posted
Jan 19, 2024
Start date
Feb 2024 (estimated)
Primary completion
Apr 2025 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jan 19, 2024

Study contacts

Ahmed Mohamed Alaa
Contact
Drahmedm.alaaa@gmail.com
01007575074
Hussein Farid mostafa wishahi
Contact
hussien.weshahi@med.au.edu.eg
01001775898
Ahmed Ragab sayed
study director · Board membership

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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