Triamcinolone Nanocapsules After Endoscopic Nasal Surgery

NCT07714525 | Recruiting Phase 2

• 1 other identifier: DU-PH-NANO-RCT-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised, single-masked, parallel-group clinical trial will evaluate the efficacy and safety of a topical triamcinolone acetonide-loaded polymeric nanocapsule formulation for postoperative care following endoscopic nasal surgery. Participants will receive either the investigational triamcinolone acetonide-loaded nanocapsule formulation or standard normal saline nasal irrigation. Postoperative nasal healing, inflammation, patient-reported sinonasal symptoms, postoperative complications, and corticosteroid-related adverse effects will be compared between the two groups.

Conditions

Chronic Rhinosinusitis (CRS); Nasal Polyps; Postoperative Healing After Endoscopic Nasal Surgery

Keywords

Triamcinolone acetonide; Nanocapsules; Polymeric nanocapsules; Endoscopic nasal surgery

Outcome Measures

Primary Outcomes (2)

• Change in Lund-Kennedy Endoscopic Score

  The Lund-Kennedy Endoscopic Score will be used to assess postoperative nasal mucosal healing and inflammation. The score ranges from 0 to 20 and is calculated by summing the scores for polyps, discharge, oedema, scarring, and crusting (each scored 0-2 on both the left and right sides). A total score of 0 indicates no disease, and a score of 20 indicates the most severe disease. Therefore, higher scores indicate a worse outcome

  Baseline, postoperative week 2, postoperative week 4, and postoperative month 3

• Change in 22-Item Sinonasal Outcome Test Score (SNOT-22)

  SNOT-22 will be used to assess participant-reported sinonasal symptoms and health-related quality of life. The total score ranges from 0 to 110 and is calculated by summing the scores for 22 individual items. Each item is rated from 0 ("No problem") to 5 ("Problem as bad as it can be"). A total score of 0 indicates no disease burden, and a score of 110 indicates the maximum disease burden. Therefore, higher scores indicate a worse outcome.

  Baseline, postoperative week 2, postoperative week 4, and postoperative month 3

Secondary Outcomes (2)

• Incidence of Postoperative Complications

  From the date of surgery through postoperative month 3

• Incidence of Corticosteroid-Related Adverse Events

  From the first administration of study treatment through postoperative month 3

Study Arms (2)

Triamcinolone Acetonide Nanocapsules

EXPERIMENTAL

Participants assigned to this arm will receive topical triamcinolone acetonide-loaded polymeric nanocapsules as postoperative nasal therapy following endoscopic nasal surgery

Drug: Triamcinolone Acetonide-Loaded Polymeric Nanocapsules

Normal Saline Irrigation

ACTIVE COMPARATOR

Participants assigned to this arm will receive standard postoperative normal saline nasal irrigation following endoscopic nasal surgery.

Other: Normal Saline Nasal Irrigation

Interventions

Normal Saline Nasal Irrigation OTHER

Participants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.

Normal Saline Irrigation

Triamcinolone Acetonide-Loaded Polymeric Nanocapsules DRUG

Triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.

Triamcinolone Acetonide Nanocapsules

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 60 years.
• Patients scheduled to undergo one of the following procedures:
• Functional endoscopic sinus surgery
• Endoscopic turbinoplasty
• Endoscopic septoplasty
• Diagnosis of chronic rhinosinusitis and/or nasal polyps requiring surgical intervention.
• Ability and willingness to provide written informed consent.
• Ability and willingness to comply with study treatment and scheduled follow-up visits.

You may not qualify if:

• Known hypersensitivity to triamcinolone acetonide.
• Known hypersensitivity to any component of the polymeric nanocapsule formulation.
• Systemic contraindication to corticosteroid therapy.
• Active severe nasal or sinonasal infection at the time of enrollment or treatment.
• Pregnancy or breastfeeding, if excluded in the approved protocol.
• Uncontrolled diabetes mellitus, if corticosteroid exposure is considered clinically relevant.
• Immunosuppression or use of immunosuppressive therapy.
• Recent use of systemic or intranasal corticosteroids within the protocol-defined washout period.
• Participation in another clinical trial.
• Any medical or psychiatric condition that may interfere with informed consent, study treatment, or follow-up.
• Inability to complete the required questionnaires or follow-up visits.

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Deraya university, faculty of pharmacy

Minya, Menia Governorate, Egypt

RECRUITING

Related Publications (8)

• Camargo GDA, Ferreira L, Schebelski DJ, Lyra AM, Barboza FM, Carletto B, Koga AY, Semianko BC, Dias DT, Lipinski LC, Novatski A, Raman V, Manfron J, Nadal JM, Farago PV. Characterization and In Vitro and In Vivo Evaluation of Tacrolimus-Loaded Poly(epsilon-Caprolactone) Nanocapsules for the Management of Atopic Dermatitis. Pharmaceutics. 2021 Nov 26;13(12):2013. doi: 10.3390/pharmaceutics13122013.

  PMID: 34959295 BACKGROUND

• Erdogar N, Akkin S, Bilensoy E. Nanocapsules for Drug Delivery: An Updated Review of the Last Decade. Recent Pat Drug Deliv Formul. 2018;12(4):252-266. doi: 10.2174/1872211313666190123153711.

  PMID: 30674269 BACKGROUND

• Kothamasu P, Kanumur H, Ravur N, Maddu C, Parasuramrajam R, Thangavel S. Nanocapsules: the weapons for novel drug delivery systems. Bioimpacts. 2012;2(2):71-81. doi: 10.5681/bi.2012.011. Epub 2012 Apr 5.

  PMID: 23678444 BACKGROUND

• Siebelt M, Korthagen N, Wei W, Groen H, Bastiaansen-Jenniskens Y, Muller C, Waarsing JH, de Jong M, Weinans H. Triamcinolone acetonide activates an anti-inflammatory and folate receptor-positive macrophage that prevents osteophytosis in vivo. Arthritis Res Ther. 2015 Dec 5;17:352. doi: 10.1186/s13075-015-0865-1.

  PMID: 26637220 BACKGROUND

• Imai S, Otsuka T, Naito A, Shimazawa M, Hara H. Triamcinolone Acetonide Suppresses Inflammation and Facilitates Vascular Barrier Function in Human Retinal Microvascular Endothelial Cells. Curr Neurovasc Res. 2017;14(3):232-241. doi: 10.2174/1567202614666170619081929.

  PMID: 28625129 BACKGROUND

• Bugten V, Nordgard S, Steinsvag S. Long-term effects of postoperative measures after sinus surgery. Eur Arch Otorhinolaryngol. 2008 May;265(5):531-7. doi: 10.1007/s00405-007-0501-z. Epub 2007 Oct 25.

  PMID: 17960410 BACKGROUND

• Eloy P, Andrews P, Poirrier AL. Postoperative care in endoscopic sinus surgery: a critical review. Curr Opin Otolaryngol Head Neck Surg. 2017 Feb;25(1):35-42. doi: 10.1097/MOO.0000000000000332.

  PMID: 27846022 BACKGROUND

• Rudmik L, Soler ZM, Orlandi RR, Stewart MG, Bhattacharyya N, Kennedy DW, Smith TL. Early postoperative care following endoscopic sinus surgery: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2011 Nov-Dec;1(6):417-30. doi: 10.1002/alr.20072. Epub 2011 Oct 29.

  PMID: 22144050 BACKGROUND

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sally Mansour Helmy

  Deraya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Mansour Helmy

CONTACT

+20 102 692 0921; aliaa.gamal@deraya.edu.eg

Aliaa Gamal Hussein

CONTACT

+201003041632; aliaa.gamal@deraya.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in parallel to receive either topical triamcinolone acetonide-loaded polymeric nanocapsules or standard normal saline nasal irrigation following endoscopic nasal surgery.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)