NCT03112330 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Canciani M, Barlocco EG, Mastella G, de Santi MM, Gardi C, Lungarella G
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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.
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.
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.
Marx RE
Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. Review.
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.
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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.
Stavrakas M, Karkos PD, Markou K, Grigoriadis N
Platelet-rich plasma in otolaryngology. J Laryngol Otol. 2016 Dec;130(12):1098-1102. Review.

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

Details for clinical trial NCT03112330

Clinical trial NCT03112330 - References