Botulinum Toxin-A Compared with Cetirizine in the Treatment of Allergic Rhinitis

Evaluating the Effects of Intranasal Injection of Botulinum Toxin-A Compared with Cetirizine on Symptoms of Rhinitis in Adult Patients with Allergic Rhinitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201208261579N3

Enrollment

Registered

2012-10-03

Start date

2010-12-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Allergic rhinitis. Vasomotor and allergic rhinitis

Interventions

Intervention 1: Intervention: Patients in the intervention group were treated with a single dose intranasal injection of BTX-A (Dysport, Ipsen Biopharm, Wrexham, UK). The procedure was applied while t

Treatment - Drugs

Control: Patients in the control group were treated with cetirizine (Abidi Co., Tehran, IRAN) 10 mg once daily for two months.

Intervention: Patients in the intervention group were treated with a single dose intranasal injection of BTX-A (Dysport, Ipsen Biopharm, Wrexham, UK). The procedure was applied while the patients wer

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Adult patients with allergic rhinitis according to the Allergic Rhinitis and its Impact on Asthma criteria, 2- Having at least three symptoms of sneezing, nasal congestion, and rhinorrhea. Exclusion criteria: 1- History of nasal anatomic abnormality, 2- Persistent asthma, 3- Long term use of systemic corticosteroids, 4- Malignancy, tuberculosis, diabetes mellitus, or other chronic systemic disease, 5- History of rhinoplasty, 6- Pregnant women, 7- Being on local corticosteroids at the time of enrollment.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sneezing. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.;Rhinorrhea. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.;Nasal congestion. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.;Nasal itching. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.;Eye irritation. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.	—

Measure

Time frame

Sneezing. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.;Rhinorrhea. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.;Nasal congestion. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.;Nasal itching. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.;Eye irritation. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire.

—

Secondary

Measure	Time frame
Quality of life. Timepoint: Before and two months after the study. Method of measurement: Rhinasthma Questionnaire.;Nasal dryness. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient.;Epistaxis. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient.;Sleepiness. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient.;Blurred vision. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient.	—

Measure

Time frame

Quality of life. Timepoint: Before and two months after the study. Method of measurement: Rhinasthma Questionnaire.;Nasal dryness. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient.;Epistaxis. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient.;Sleepiness. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient.;Blurred vision. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Saghi Amini

Isfahan University of Medical Sciences

drsaghi210@hotmail.com00

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026