Chronic Rhinosinusitis (CRS)Phase 2NCT07714525
Triamcinolone Nanocapsules After Endoscopic Nasal Surgery
A Phase 2 study testing Triamcinolone Acetonide-Loaded Polymeric Nanocapsules and Normal Saline Nasal Irrigation in people with Chronic Rhinosinusitis (CRS) and Nasal Polyps, run by Deraya University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Rhinosinusitis (CRS), Nasal Polyps, Postoperative Healing After Endoscopic Nasal Surgery
- What is being tested?
- Triamcinolone Acetonide-Loaded Polymeric Nanocapsules and Normal Saline Nasal Irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Deraya university, faculty of pharmacy
Minya, Menia Governorate
Aliaa Gamal Hussien, +20 1003041632, aliaa.gamal@deraya.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Rhinosinusitis (CRS), Nasal Polyps, Postoperative Healing After Endoscopic Nasal Surgery
- Being tested
- Triamcinolone Acetonide-Loaded Polymeric Nanocapsules, Normal Saline Nasal Irrigation
- Keywords
- Triamcinolone acetonide, Nanocapsules, Polymeric nanocapsules, Endoscopic nasal surgery
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide-Loaded Polymeric NanocapsulesDrug
Triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.
Normal Saline Nasal IrrigationOther
Participants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone Acetonide Nanocapsules | Experimental | Participants assigned to this arm will receive topical triamcinolone acetonide-loaded polymeric nanocapsules as postoperative nasal therapy following endoscopic nasal surgery Receives: Drug: Triamcinolone Acetonide-Loaded Polymeric Nanocapsules |
| Normal Saline Irrigation | Active comparator | Participants assigned to this arm will receive standard postoperative normal saline nasal irrigation following endoscopic nasal surgery. Receives: Other: Normal Saline Nasal Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lund-Kennedy Endoscopic Score
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
Measured: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
Change in 22-Item Sinonasal Outcome Test Score (SNOT-22)
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.
Measured: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
Secondary outcomes (2)
Incidence of Postoperative Complications
The number and percentage of participants experiencing protocol-defined postoperative complications will be recorded.
Measured: From the date of surgery through postoperative month 3
Incidence of Corticosteroid-Related Adverse Events
The number and percentage of participants experiencing local or systemic adverse events considered related to topical triamcinolone acetonide will be recorded.
Measured: From the first administration of study treatment through postoperative month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (CRS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in parallel to receive either topical triamcinolone acetonide-loaded polymeric nanocapsules or standard normal saline nasal irrigation following endoscopic nasal surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sally Mansour Helmy, Principal investigator, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714525
- Sponsor's protocol ID
- DU-PH-NANO-RCT-004
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34959295Erdogar 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.
PubMed 30674269Kothamasu 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.
PubMed 23678444Siebelt 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.
PubMed 26637220Imai 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.
PubMed 28625129Bugten 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.
PubMed 17960410Eloy 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.
PubMed 27846022Rudmik 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.
PubMed 22144050