A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis

Study Overview
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Brief Summary
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The goal of the suggested research is to develop a treatment option using platelet rich plasma injection for regeneration of atropic nasal mucosa. Specific aims of the suggested research is to (1) access the effect of platelet rich plasma in the patients with atropic rhinitis . Moreover, we will (2) compare the conservative treatments including saline nasal irrigation or saline nasal spray.

Detailed Description
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Clinical trials of platelet rich plasma injection for regeneration of atropic nasal mucosa. Injection interval and follow-up duration Injection interval 2 weeks (upto total 3 consecutive injection) Follow-up duration: 6 months Observation items, clinical assessment items and evaluation method Access the nasal mucosal status using nasal speculum. Access the nasal mucociliary function using saccharin test (primary outcome; once per month). Fill in the nasal symptom scores using Nasal Obstruction Symptom Evaluation(NOSE) Instrument, Sino-Nasal outcome Test 20, and Visual analog scale (secondary outcome; once per month) The other atrophic rhinitis patients who did not want to perform platelet rich plasma injection Random allocation to saline nasal irrigation or saline nasal spray group Perform same observation items, clinical assessment items and evaluation method as well as platelet rich plasma injection group

Official Title
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A Single-center, Non-randomized, Open, Single-arm Confirmatory Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Patients With Atrophic Rhinitis

Conditions
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Atrophic Rhinitis

Intervention / Treatment
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* Device: Plasma rich platelet injection
* Device: Saline nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (>18 years) Complaint of atrophic rhinitis symptoms including nasal crusting, nasal burning sensation, and postnasal drip Atrophic rhinitis view on nasal endoscopic finding Patients who informed sufficient about other atrophic rhinitis treatment options including Young's operation, lubricants, or saline irrigation, but, want more other active treatment option. Exclusion Criteria: Platelet related disorders Low serum platelet (<100,000/㎕) Other hematologic disorders Septicemia Take anticoagulant drugs

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet rich plasma injection group<br>To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis | Device: Plasma rich platelet injection<br>* Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa<br>Device: Saline nasal spray<br>* two puffs of isotonic saline nasal spray twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of mucociliary clearance function using the saccharin test | The change in saccharin test time of the 2, 4, 8, 12, and 24th week after first treatment | 2, 4, 8, 12, and 24th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument | The change in NOSE total scores of the 2, 4, 8, 12, and 24th week after first treatment | 2, 4, 8, 12, and 24th week | 
| The change of nasal symptoms using the Sino-Nasal outcome Test 20 | The change in Sino-Nasal outcome Test 20 scores of the 2, 4, 8, 12, and 24th week after first treatment | 2, 4, 8, 12, and 24th week | 
| The change of nasal symptoms using the Visual analog scale | The change in Visual analog scale scores of the 2, 4, 8, 12, and 24th week after first treatment | 2, 4, 8, 12, and 24th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrophic rhinitis