Triamcinolone Nanocapsules After Endoscopic Nasal Surgery
24 juli 2026 bijgewerkt door: Deraya University
Clinical Evaluation of Triamcinolone Acetonide-loaded Nanoparticles For Nasal Postoperative Application
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Postoperative care following functional endoscopic sinus surgery and other endoscopic nasal procedures is important for reducing inflammation, supporting mucosal healing, and preventing complications and disease recurrence.
Conventional topical nasal treatments may be rapidly cleared from the nasal cavity, which may reduce their contact time with the postoperative nasal mucosa.
The investigational formulation contains triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method. The nanocapsule delivery system is intended to improve local drug retention, enhance drug stability, and provide controlled release of triamcinolone acetonide at the postoperative nasal tissues.
Eligible participants will be randomly assigned to receive either topical triamcinolone acetonide-loaded polymeric nanocapsules or standard normal saline nasal irrigation following endoscopic nasal surgery.
Participants will be followed using endoscopic clinical assessments, patient-reported sinonasal symptom questionnaires, evaluation of postoperative complications, and monitoring for local or systemic corticosteroid-related adverse effects.
Studietype
Ingrijpend
Inschrijving (Geschat)
50
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Sally Mansour Helmy
- Telefoonnummer: +20 102 692 0921
- E-mail: aliaa.gamal@deraya.edu.eg
Studie Contact Back-up
- Naam: Aliaa Gamal Hussein
- Telefoonnummer: +201003041632
- E-mail: aliaa.gamal@deraya.edu.eg
Studie Locaties
-
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Menia Governorate
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Minya, Menia Governorate, Egypte
- Werving
- Deraya university, faculty of pharmacy
-
Contact:
- Aliaa Gamal Hussien
- Telefoonnummer: +20 1003041632
- E-mail: aliaa.gamal@deraya.edu.eg
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Triamcinolone Acetonide Nanocapsules
Participants assigned to this arm will receive topical triamcinolone acetonide-loaded polymeric nanocapsules as postoperative nasal therapy following endoscopic nasal surgery
|
Triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.
|
|
Actieve vergelijker: Normal Saline Irrigation
Participants assigned to this arm will receive standard postoperative normal saline nasal irrigation following endoscopic nasal surgery.
|
Participants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Lund-Kennedy Endoscopic Score
Tijdsspanne: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
|
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
|
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Change in 22-Item Sinonasal Outcome Test Score (SNOT-22)
Tijdsspanne: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
|
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.
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Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of Postoperative Complications
Tijdsspanne: From the date of surgery through postoperative month 3
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The number and percentage of participants experiencing protocol-defined postoperative complications will be recorded.
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From the date of surgery through postoperative month 3
|
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Incidence of Corticosteroid-Related Adverse Events
Tijdsspanne: From the first administration of study treatment through postoperative month 3
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The number and percentage of participants experiencing local or systemic adverse events considered related to topical triamcinolone acetonide will be recorded.
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From the first administration of study treatment through postoperative month 3
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Sally Mansour Helmy, Deraya University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 mei 2026
Primaire voltooiing (Geschat)
1 mei 2027
Studie voltooiing (Geschat)
1 juni 2027
Studieregistratiedata
Eerst ingediend
15 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
15 juli 2026
Eerst geplaatst (Werkelijk)
20 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
24 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DU-PH-NANO-RCT-004
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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