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Use of Botulinum Toxin for Treatment of Idiopathic Rhinitis

Use of Botulinum Toxin Type A for Treatment of Idiopathic Rhinitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4jbw4s
Enrollment
Unknown
Registered
2020-07-23
Start date
2018-05-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

idiopathic rhinitis

Interventions

Patients were divided randomly into two groups, a group that received botulinum toxin and the control group. After nasal topical application of lidocaine with cotton swab, 20 U of toxin, diluted in 1
Drug
D12.776.124.790.651.114.580.450

Sponsors

Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Criteria for inclusion in the study: Patients older than 18 years who signed the informed consent form and understood the explanation of the study, carried out by the researcher himself. Patients of both sexes, without distinction of race. Patients diagnosed for idiopathic rhinitis for at least one year, ie patients in whom the other etiologies of rhinitis (allergic rhinitis, non-allergic, drug, hormonal, drug and occupational eosinophilic rhinitis) were excluded from the clinical history , physical examination, nasal cytology examination with eosinophils below 2%, and immediate hypersensitivity skin test for negative inhalants.

Exclusion criteria

Exclusion criteria: Exclusion criteria in the study: Patients with other nasal anatomical abnormalities, such as nasosinusal polyposis or obstructive nasal septum deviation. Patients with acute or chronic rhinosinusitis. Patients with severe systemic diseases, glaucoma or prostatic hypertrophy that may be aggravated by anticholinergic therapy. Patients with immediate hypersensitivity skin test for positive inhalants, nasal cytological examination with eosinophilia greater than 2%.Patients who received rhinitis medications prior to the immediate inhalant hypersensitivity skin test. Patients pregnant or likely to be pregnant.

Design outcomes

Primary

MeasureTime frame
The aim of this study is to analyze the effects of intranasal injection of BTX-A in the control of symptoms of idiopathic rhinitis, ;Improvement of rhinitis symptoms in individuals, at least 25%, assessed by a symptom score, measurement of nasal inspiratory peak flow, acoustic rhinometry and visual analog scale (VAS). Data collected in the first, second, fourth, eighth and twelfth weeks after the intervention.

Secondary

MeasureTime frame
More marked improvement in the symptoms of runny nose and nasal obstruction, already in the first week after the intervention, persisting until the twelfth week.;Evaluate possible adverse effects.

Countries

Brazil

Contacts

Public ContactDaniel;Thiago Salgado;Carvalho

Faculdade de Medicina da Universidade de São Paulo;Faculdade de Medicina da Universidade de São Paulo

danimed32@yahoo.com.br;thiagocarvalho@usp.br+55(11)30880299;+55-11-30880299

Outcome results

None listed

Source: REBEC (via WHO ICTRP)