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A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis

A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis - Effect of Botrinum Toxin type A therapy in Patients with Japanese cedar pollinosis (E-BOAT study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001657
Enrollment
32
Registered
2009-01-26
Start date
2009-01-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Japanese cedar pollinosis

Interventions

Botulinum toxin A (20 U, 0.2ml) is injected into each nasal cavity just before the beginning of pollen scattering. Ten mg of loratadine and/ or mometazone nasal spray can be used as a backup drug. S

Sponsors

Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine, University of Yamanash
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)a history of Japanese cedar pollinosis 2)CAP-RAST against Japanese cedar pollen ≥2

Exclusion criteria

Exclusion criteria: 1)pregnancy or possibility of pregnancy 2)history of heart disease 3)history of glaucoma 4)history of prostate hypertrophy 5)history of neuro-muscular disease 6)history of stroke 7)accompanying acute rhinitis or sinusitis 8)use of any anti-allergy drugs at the beginning of the study 9)history of nose/sinus surgery 10)prominent deviation of the nasal septum

Design outcomes

Primary

MeasureTime frame
Symptom score, symptom-medication score, QOL estimation, rhinomanometry

Secondary

MeasureTime frame
adverse events

Countries

Japan

Contacts

Public ContactAtsushi Kamijo

University of Yamanashi Department of Otorhinolaryngology, Head and Neck Surgery

botoxchiken@live.jp055-273-6769

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026