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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03112330
Acronym
ARPRP
Enrollment
22
Registered
2017-04-13
Start date
2017-06-08
Completion date
2019-04-01
Last updated
2019-04-04

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

Conditions

Atrophic Rhinitis

Keywords

atrophic rhinitis

Brief summary

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

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

Interventions

two puffs of isotonic saline nasal spray twice daily

DEVICEPlasma rich platelet injection

Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa

Sponsors

Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The change of mucociliary clearance function using the saccharin test2, 4, 8, 12, and 24th weekThe change in saccharin test time of the 2, 4, 8, 12, and 24th week after first treatment

Secondary

MeasureTime frameDescription
The change of nasal symptoms using the Visual analog scale2, 4, 8, 12, and 24th weekThe change in Visual analog scale scores of the 2, 4, 8, 12, and 24th week after first treatment
The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument2, 4, 8, 12, and 24th weekThe change in NOSE total scores of the 2, 4, 8, 12, and 24th week after first treatment
The change of nasal symptoms using the Sino-Nasal outcome Test 202, 4, 8, 12, and 24th weekThe change in Sino-Nasal outcome Test 20 scores of the 2, 4, 8, 12, and 24th week after first treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026