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Triamcinolone Nanocapsules After Endoscopic Nasal Surgery

15. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
    • Menia Governorate
      • Minya, Menia Governorate, Egypten
        • Rekruttering
        • Deraya university, faculty of pharmacy
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Triamcinolone Acetonide Nanocapsules
Participants assigned to this arm will receive topical triamcinolone acetonide-loaded polymeric nanocapsules as postoperative nasal therapy following endoscopic nasal surgery
Medicin: Triamcinolone Acetonide-Loaded Polymeric Nanocapsules
Triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.
Aktiv komparator: Normal Saline Irrigation
Participants assigned to this arm will receive standard postoperative normal saline nasal irrigation following endoscopic nasal surgery.
Andet: Normal Saline Nasal Irrigation
Participants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Lund-Kennedy Endoscopic Score
Tidsramme: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
Postoperative nasal mucosal healing and inflammation will be assessed using the Lund-Kennedy endoscopic scoring system.
Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
Change in 22-Item Sinonasal Outcome Test Score
Tidsramme: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
Participant-reported sinonasal symptoms and health-related quality of life will be assessed using the 22-Item Sinonasal Outcome Test, SNOT-22.
Baseline, postoperative week 2, postoperative week 4, and postoperative month 3

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Postoperative Complications
Tidsramme: From the date of surgery through postoperative month 3
The number and percentage of participants experiencing protocol-defined postoperative complications will be recorded.
From the date of surgery through postoperative month 3
Incidence of Corticosteroid-Related Adverse Events
Tidsramme: From the first administration of study treatment through postoperative month 3
The number and percentage of participants experiencing local or systemic adverse events considered related to topical triamcinolone acetonide will be recorded.
From the first administration of study treatment through postoperative month 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Deraya University

Efterforskere

  • Ledende efterforsker: Sally Mansour Helmy, Deraya University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DU-PH-NANO-RCT-004

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Næsepolypper

Kliniske forsøg med Triamcinolone Acetonide-Loaded Polymeric Nanocapsules

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