Triamcinolone-loaded nanocapsules after endoscopic nasal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, single-masked study compares a novel topical triamcinolone acetonide formulation within polymeric nanocapsules to standard saline nasal irrigation for postoperative care after endoscopic nasal procedures. Participants will be followed with endoscopic assessments, patient-reported symptom questionnaires, and monitoring for healing, inflammation, complications, and corticosteroid-related adverse effects. The goal is to see if the nanocapsule delivery improves mucosal retention and provides better local treatment with controlled drug release. Eligible adults with chronic rhinosinusitis and/or nasal polyps undergoing functional endoscopic sinus surgery or related procedures will be assigned to the nanocapsule treatment or saline and monitored through healing and safety outcomes. The study will help determine if this approach can enhance recovery and reduce postoperative issues.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Sally Mansour Helmy — Deraya University
• Study coordinator: Sally Mansour Helmy
• Email: aliaa.gamal@deraya.edu.eg
• Phone: +20 102 692 0921

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.