RecruitingPhase 2NCT07714525

Triamcinolone Nanocapsules After Endoscopic Nasal Surgery

Clinical Evaluation of Triamcinolone Acetonide-loaded Nanoparticles For Nasal Postoperative Application


Sponsor

Deraya University

Enrollment

50 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria8

  • 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 Criteria11

  • 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.

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Interventions

DRUGTriamcinolone Acetonide-Loaded Polymeric Nanocapsules

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

OTHERNormal Saline Nasal Irrigation

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


Locations(1)

Deraya university, faculty of pharmacy

Minya, Menia Governorate, Egypt

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NCT07714525


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