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

Seoul St. Mary's Hospital

Status: Completed

Conditions: Atrophic Rhinitis

Treatments: Device: Plasma rich platelet injection; Device: Saline nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT03112330

CMCENT-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 22 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

platelet rich plasma injection group

Experimental group

Description:

To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis

Treatment:

Device: Saline nasal spray

Device: Plasma rich platelet injection