The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa
NCT ID: NCT05919316
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-07-04
2024-04-30
Brief Summary
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The hypothesis for this study is Intranasal phototherapy will reduce mucosal inflammation without mucosal damage and is comparable to intranasal steroids in allergic rhinitis patients
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Detailed Description
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1. To subjectively and objectively compare the efficacy of intranasal phototherapy and intranasal corticosteroids in treating allergic rhinitis via assessment of rhinomanometry, peak nasal inspiratory flow (PNIF) and visual analogue scale(VAS) score.
2. To determine mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
3. To determine mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
Patients who meet the criteria to join the study will be randomized in a single-blinded manner(investigator). Patients will be given information about the study and consent form, patients will be randomized to 2 treatment group (rhinophototherapy and Nasonex nasal spray). Patients will be evaluated before and after treatment in two weeks time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rhinophototherapy
Intranasal Rhinophototherapy is an electronic allergic rhinitis treatment device (brand Bionette) also a medical device that producing low level narrow band red light at a wavelength of 630nm. It is a Class B medical device (registration of Malaysia number GB67793908818). It is powered by two alkaline button batteries with a dimension of 52mm x 40mm and weighing less than 20g . Light is produced via nasal prongs which are to be inserted into both nostrils. Plastic nasal cannula are available and can be replaced to ensure sterility and prevent transmission of infection.
Rhinophototherapy
Intranasal rhinophotometer to be used at home for 4.5 minutes three times daily for 14 days
Intranasal Corticosteroids
Mometasone furoate will be available in the form of Nasonex Nasal Spray. It has a dose of 50 mcg/dose mometasone furoate per spray, registration no: MAL20001010AZ, distributed by: Merck Sharp \& Dohme (Malaysia) Sdn. Bhd.
Nasonex Nasal Spray
50mcg/dose, 2 sprays each nostril (morning or evening) once daily for 14 days
Interventions
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Rhinophototherapy
Intranasal rhinophotometer to be used at home for 4.5 minutes three times daily for 14 days
Nasonex Nasal Spray
50mcg/dose, 2 sprays each nostril (morning or evening) once daily for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed allergic rhinitis
* Allergic rhinitis is confirmed via positive skin prick test or serum Immunoglobulin E
Exclusion Criteria
* Refused nasal biopsy
* Usage of intranasal corticosteroids and/or antihistamine sprays for the past 1 month
* Consumption of oral leukotriene receptor antagonist or oral steroids for the past 1 month
* Concomitant nasal pathology (malignancy, chronic rhinosinusitis with nasal polyposis, severe deviated nasal septum)
* Bleeding disorder or on anticoagulant/antiplatelet therapy
* Recent URTI/Covid-19 within past 14 days
* Pregnancy
18 Years
ALL
Yes
Sponsors
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National University of Malaysia
OTHER
Responsible Party
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Principal Investigators
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Hardip Singh Gendeh
Role: PRINCIPAL_INVESTIGATOR
Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre
Locations
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Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras
Kuala Lumpur, Cheras, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GGPM-2022-028
Identifier Type: -
Identifier Source: org_study_id
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