Insulin Intratympanic Application

June 14, 2026 updated by: Soad Ali, Deraya University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt
        • Minia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: insulin insitu gel
formulated instue-gel was added for foam that placed by ENT surgeon after graft addition
Drug: Insulin (Humulin)
insulin was formulated as insitu gel
Placebo Comparator: placebo group
empty foam was placed after surgery
Other: foam
Plain foam

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deraya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2026

Primary Completion (Actual)

May 15, 2026

Study Completion (Actual)

May 30, 2026

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 14, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 April 2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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