Insulin Intratympanic Application

NCT07535827 | Enrolling By Invitation Early Phase 1

• 1 other identifier: 2 April 2026
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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

Keywords

tympanic membran; insulin; insitu gel; graft technique

Outcome Measures

Primary Outcomes (1)

• Perforation size

  endoscopic otoscopy, with graft uptake classified as complete, partial, or failed/reperforated

  1 month

Study Arms (2)

insulin insitu gel

EXPERIMENTAL

formulated instue-gel was added for foam that placed by ENT surgeon after graft addition

Drug: Insulin (Humulin)

placebo group

PLACEBO COMPARATOR

empty foam was placed after surgery

Other: foam

Interventions

Insulin (Humulin) DRUG

insulin was formulated as insitu gel

insulin insitu gel

foam OTHER

Plain foam

placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Minia university hospital

Minya, Egypt

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor Daraya university

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 17, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)