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

April 2, 2019 updated by: Sung Won Kim, Seoul St. Mary's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: platelet rich plasma injection group
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
Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
Device: Saline nasal spray
two puffs of isotonic saline nasal spray twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of mucociliary clearance function using the saccharin test
Time Frame: 2, 4, 8, 12, and 24th week
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
Time Frame: 2, 4, 8, 12, and 24th week
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
Time Frame: 2, 4, 8, 12, and 24th week
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
Time Frame: 2, 4, 8, 12, and 24th week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Investigators

  • Study Chair: Sung Won Kim, MD, PhD, Seoul St. Mary'S Hospital
  • Principal Investigator: Do Hyun Kim, MD, PhD, Seoul St. Mary'S Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMCENT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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