Insulin Intratympanic Application

Topical Insulin Insitu-gel as a Wound Healing Accelerator and Anti-inflammatory Agent for Persistent Suppurative Otitis Media in RCT

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07535827

Enrollment

Registered

2026-04-17

Start date

2026-03-20

Completion date

2026-05-30

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tympanic Membrane Perforation

Keywords

tympanic membran, insulin, insitu gel, graft technique

Brief summary

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 March 2026 to May 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

Interventions

DRUGInsulin (Humulin)

insulin was formulated as insitu gel

OTHERfoam

Plain foam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* aged 18 years or older, * with a confirmed diagnosis of tubotympanic CSOM without discharge for at least three months, * an intact ossicular chain, normal middle ear mucosa on otoscopic or endoscopic examination, * conductive hearing loss indicated by an air-bone gap less than 30 dB

Exclusion criteria

* unfit for general anesthesia, * had cervical spine disorders limiting operative positioning, * active otorrhea, granulation tissue, or mucosal inflammation

Design outcomes

Primary

Measure	Time frame	Description
Perforation size	1 month	endoscopic otoscopy, with graft uptake classified as complete, partial, or failed/reperforated

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026