Insulin Insitu-Gel for Tympanic Membrane Perforations: Early Phase 1 RCT
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov registered Early Phase 1 trial NCT07535827 evaluating insulin insitu-gel formulation for tympanic membrane perforation healing. The randomized controlled study at Minia University Hospital enrolled participants from January 2025 to March 2026, comparing insulin insitu-gel (Humulin with chitosan, polyvinyl alcohol, and Pluronic F127) against foam control. Primary outcome was perforation healing at 1-week, 1-month, and 2-month follow-ups; secondary outcomes included hearing scores. Results showed significantly superior healing in the insulin group versus control.
What changed
A new clinical trial registration documents Early Phase 1 study NCT07535827 investigating insulin insitu-gel formulation for treating chronic tympanic membrane perforations. The randomized controlled trial compared insulin insitu-gel (Humulin with penetration enhancer glycerol) against foam placebo in 48+ human volunteers over approximately 14 months.
For affected parties, this trial registration provides preclinical and clinical evidence that insulin insitu-gel significantly accelerates tympanic membrane healing compared to standard foam treatment. Healthcare providers and trial sponsors should note this early-phase finding while recognizing that Phase 1 results require further validation in larger trials before clinical adoption. The trial is registered under FDAAA 2007 requirements and subject to NIH reporting obligations.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Insulin Intratympanic Application
Early Phase 1 NCT07535827 Kind: EARLY_PHASE1 Apr 17, 2026
Abstract
The objective of the present study was to study the impact of insulin insitu-gel formulation on healing progress after surgical procedures for treatment of dry tympanic membrane perforation for at least three consecutive months. At the beginning, an insulin insitu-gel was prepared from three different polymers compatible with insulin physiochemically and reported to be vain on insulin efficacy or safety. Insulin insitu-gel was prepared using chitosan, polyvinyl alcohol, and Pluronic F127 with glycerol as a penetration enhancer. Selection of an optimized formulation through in situ gel characterization and in vitro drug release kinetics then the formulation was evaluated for healing efficacy on human volunteers in RCT. A randomized controlled clinical study was implemented for clinical evaluation of insitu-gel formulation activity in the Department of Otorhinolaryngology, Minia University Hospital, from January 2025 to March 2026. Perforation healing signs as a primary indicator was followed and reported in three follow-up visits (1 week, 1 month, and 2 months) in addition hearing score pre- and post-surgery as secondary outcomes. Results of a clinical study showed that the healing is significantly superior in the insulin group than in the control group
Conditions: Tympanic Membrane Perforation
Interventions: Insulin (Humulin), foam
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.