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

Atrophic Rhinitis Clinical Trial

— ARPRP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112330
• Other study ID #: CMCENT-01
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Rhinitis
• Atrophy
• Rhinitis

Intervention

Device:
• Plasma rich platelet injection
Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
• Saline nasal spray
two puffs of isotonic saline nasal spray twice daily

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

Canciani M, Barlocco EG, Mastella G, de Santi MM, Gardi C, Lungarella G. The saccharin method for testing mucociliary function in patients suspected of having primary ciliary dyskinesia. Pediatr Pulmonol. 1988;5(4):210-4. — View Citation

Friji MT, Gopalakrishnan S, Verma SK, Parida PK, Mohapatra DP. New regenerative approach to atrophic rhinitis using autologous lipoaspirate transfer and platelet-rich plasma in five patients: Our Experience. Clin Otolaryngol. 2014 Oct;39(5):289-92. doi: 10.1111/coa.12269. — View Citation

Hildenbrand T, Weber RK, Brehmer D. Rhinitis sicca, dry nose and atrophic rhinitis: a review of the literature. Eur Arch Otorhinolaryngol. 2011 Jan;268(1):17-26. doi: 10.1007/s00405-010-1391-z. Epub 2010 Sep 29. Review. — View Citation

Jaswal A, Jana AK, Sikder B, Nandi TK, Sadhukhan SK, Das A. Novel treatment of atrophic rhinitis: early results. Eur Arch Otorhinolaryngol. 2008 Oct;265(10):1211-7. doi: 10.1007/s00405-008-0629-5. Epub 2008 Mar 4. — View Citation

Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. Review. — View Citation

Mishra A, Kawatra R, Gola M. Interventions for atrophic rhinitis. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD008280. doi: 10.1002/14651858.CD008280.pub2. Review. — View Citation

Modrzynski M. Hyaluronic acid gel in the treatment of empty nose syndrome. Am J Rhinol Allergy. 2011 Mar-Apr;25(2):103-6. doi: 10.2500/ajra.2011.25.3577. — View Citation

Stavrakas M, Karkos PD, Markou K, Grigoriadis N. Platelet-rich plasma in otolaryngology. J Laryngol Otol. 2016 Dec;130(12):1098-1102. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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