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Completed

NCT Number: NCT07535827

Insulin Intratympanic Application

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Minia university hospital

Minya, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin (Humulin)

Drug

insulin was formulated as insitu gel

foam

Other

Plain foam

Primary outcomes

  1. Perforation size

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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