Triamcinolone Nanocapsules After Endoscopic Nasal Surgery

July 15, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Menia Governorate
      • Minya, Menia Governorate, Egypt
        • Recruiting
        • Deraya university, faculty of pharmacy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triamcinolone Acetonide Nanocapsules
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
Triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.
Active Comparator: Normal Saline Irrigation
Participants assigned to this arm will receive standard postoperative normal saline nasal irrigation following endoscopic nasal surgery.
Other: Normal Saline Nasal Irrigation
Participants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lund-Kennedy Endoscopic Score
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Complications
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deraya University

Investigators

  • Principal Investigator: Sally Mansour Helmy, Deraya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DU-PH-NANO-RCT-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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