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NCT05412745
Class I Medical Device on Post-surgical Scars
NA trial testing Kaloidon Plus in Cicatrix in 64 participants. Completed in 10 September 2022.
10 September 2022
Quick facts
| Lead sponsor | University of Rome Tor Vergata |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 64 |
| Start date | 1 May 2022 |
| Primary completion | 10 September 2022 |
| Estimated completion | 10 September 2022 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Kaloidon Plus
- silicone gel
Conditions studied
- Cicatrix — all drugs for Cicatrix →
- Post-Surgical Complication — all drugs for Post-Surgical Complication →
- Scar Itching — all drugs for Scar Itching →
- Keloid — all drugs for Keloid →
Sponsor
University of Rome Tor Vergata
Who can join
Adults 18 to 70, any sex, with Cicatrix or Post-Surgical Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To compare the effect of a class I pullulan based medical device containing Allium cepa \& HA versus a class I medical device silicone gel on new post-surgical wounds
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
From In Silico Simulation between TGF-<i>β</i> Receptors and Quercetin to Clinical Insight of a Medical Device Containing <i>Allium cepa</i>: Its Efficacy and Tolerability on Post-Surgical Scars.
Cosio T, Costanza G, Coniglione F, Romeo A, et al · · 2023 · cited 2× · PMID 37629638 · DOI 10.3390/life13081781 -
Current State of Clinical Trials for Keloid Management: An Analysis of Trials Registered on ClinicalTrials.gov.
Park S, Li D, Guo L, Xu X. · · 2026 · PMID 42077711 · DOI 10.7759/cureus.106243
Verify or expand the search:
- PubMed search for NCT05412745
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cicatrix
Currently open trials in the same condition.
- NCT06122090 — Treatment of Hypopigmented Scars With Bimatoprost · Phase 2 · recruiting
Other University of Rome Tor Vergata trials
Trials by the same sponsor.
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- NCT07286461 — VIROMARKERS GA n.101194735 - CMV and TTV Biomarkers Study Protocol · not yet recruiting
- NCT07067749 — Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer · Phase 3 · recruiting
- NCT06711744 — ISQ Differences Between Different Implants in Post-extraction Sockets · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05412745 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Rome Tor Vergata
- Last refreshed: 14 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05412745.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing