The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa Of Allergic Rhinitis Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of this study to compare the efficacy of Rhinophototherapy to Intranasal Corticosteroids on the the nasal mucosa of allergic rhinitis patients. The main question to answer is: Does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids? 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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Adult patients 18 years and above
• Newly diagnosed allergic rhinitis
• Allergic rhinitis is confirmed via positive skin prick test or serum Immunoglobulin E
Locations
Other Locations
Malaysia
Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras
RECRUITING
Kuala Lumpur
Contact Information
Primary
Hardip Singh Gendeh
hardip.gendeh@ppukm.ukm.edu.my
0391456576
Time Frame
Start Date: 2023-07-04
Estimated Completion Date: 2024-04-30
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: National University of Malaysia