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The effect of vitamin A in patients with sinusitis with nasal polyps

A prospective open-label randomized trial of tretinoin in patients with chronic rhinosinusitis with nasal polyps

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-36y8cw
Enrollment
Unknown
Registered
2018-12-26
Start date
2018-07-25
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

Nasal polyp. Nasal Polyps. Chronic sinusitis. Sinusitis

Interventions

Participation in the study will be offered orally to all thirty eligible patients who are referred to the Rhinology Outpatient Clinic. CONTROL GROUP: 15 subjects At admission, all patients should b
Drug
E02.319

Sponsors

Hospital das Clínicas da UNICAMP/Faculdade de Ciências Médicas.
Lead Sponsor
Hospital das Clínicas da UNICAMP/Faculdade de Ciências Médicas.
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient with chronic rhinosinusitis with bilateral nasal polyps; with or without allergy; with or without asthma; from any gender; older than 18 years old.

Exclusion criteria

Exclusion criteria: Patients younger than 18 years; women of childbearing or non-sterilized age; current or previous use of isotretinoin; history of nasal surgery for less than 5 years; non-controlled diabetic patients or poorly controlled hepatopathies and nephropathies; patients with cystic fibrosis or mucociliary diseases; presence of larger nasal tumors or malformations; cocaine or other inhaled drug user; patients with primary or secondary immunodeficiencies, coagulopathies, blood dysplasias, systemic or granulomatous vasculitis.

Design outcomes

Primary

MeasureTime frame
Reduction of nasal polyps volume, evaluated by nasofibroscopy, CT scan, and quality of life questionnaire, depicted as a reduction of at least 50% of polyps volume to nasofibroscopy and a reduction of 10% of the scores hailed from CT scan and quality of life questionnaire. Data collected 3 months before the intervention and 3 months after the intervention.

Secondary

MeasureTime frame
Decreased Th2 inflammatory cytokines present in the nasal polyp, measured by multiplex assays, present in homogenates of biopsy fragments, performed 3 months before the intervention and hailed months after the intervention.

Countries

Brazil

Contacts

Public ContactMarcelo Antonio

Departamento de Oftalmologia e Otorrinolaringologia, ambulatório de Rinologia

marceloaorl@hotmail.com+55-019-35217524

Outcome results

None listed

Source: REBEC (via WHO ICTRP)