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Effects of Botulinum toxin A addition to allergen specific immunotherapy for treating Allergic Rhinitis

Effects of Botulinum toxin A addition to allergen specific immunotherapy for treating Allergic Rhinitis

Status
Unknown
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220914004
Enrollment
92
Registered
2022-09-14
Start date
2020-10-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with allergic rhinitis, age between 18-60 years old Botulinum toxins A, Immunotherapy, Allergic Rhinitis, Vasomotor Rhinitis

Interventions

Botulinum toxin A
Inject 10 units (1ml) each of prepared solution (BTA) over the inferior turbinates and posterior lateral nasal walls in both nasal cavities via the nasal endoscopy, overall 40 units (10U/1 point). Kee
Active Comparator Drug,Placebo Comparator Drug
Injection of Botulinum toxin A ,Injection of 0.9% normal saline

Sponsors

Faculty of Medicine of Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patient diagnosed as allergic rhinitis by clinical symptoms and confirmed by skin prick test according to ARIA guideline. 2. Age 18 years to 60 years 3. Failed to conventional pharmacological treatment (patients still have moderate to severe symptoms according to ARIA guideline or VAS at least 5) 4. Currently on immunotherapy at the maintenance dose

Exclusion criteria

Exclusion criteria: 1 Pregnancy 2 Acute or chronic rhinosinusitis 3 Previous allergy to Botox or local anesthetic agents 4 Underlying neuromuscular disorders e.g. myasthenia gravis 5 On any anti-allergic drugs within 2 weeks prior to study 6 Prior nasal surgery

Design outcomes

Primary

MeasureTime frame
nasal symtoms and quality of life at 4 and 8 week after intervention individual and total nasal symptoms score, RCQ-36

Secondary

MeasureTime frame
adverse events at day 0, 4 and 8 week after intervention report

Countries

Thailand

Contacts

Public ContactAvika Meksukree

Faculty of Medicine, Chulalongkorn University

avika.msk@gmail.com0818503382

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026