Tympanic Membrane PerforationEarly Phase 1NCT07535827
Insulin Intratympanic Application
A Early Phase 1 study testing Insulin (Humulin) and foam in people with Tympanic Membrane Perforation, run by Deraya University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Insulin (Humulin) and foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2026to 30 May 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- unfit for general anesthesia,
- had cervical spine disorders limiting operative positioning,
- active otorrhea, granulation tissue, or mucosal inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Insulin (Humulin), foam
- Keywords
- tympanic membran, insulin, insitu gel, graft technique
- Medical subject headings
- Tympanic Membrane Perforation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin (Humulin)Drug
insulin was formulated as insitu gel
foamOther
Plain foam
| Study group | Role | What they receive |
|---|---|---|
| insulin insitu gel | Experimental | formulated instue-gel was added for foam that placed by ENT surgeon after graft addition Receives: Drug: Insulin (Humulin) |
| placebo group | Placebo comparator | empty foam was placed after surgery Receives: Other: foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perforation size
endoscopic otoscopy, with graft uptake classified as complete, partial, or failed/reperforated
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Mar 2026
- Primary completion15 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535827
- Sponsor's protocol ID
- DU-CSR 111
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Insulin Insitu-gel as a Wound Healing Accelerator and Anti-inflammatory Agent for Persistent Suppurative Otitis Media in RCT
- ClinicalTrials.gov ID
- NCT07535827
- Acronym / sponsor ID
- DU-CSR 111
- Conditions
- Tympanic Membrane Perforation
- Keywords
- tympanic membran, insulin, insitu gel, graft technique
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin insitu gel | Experimental | Drug: Insulin (Humulin)formulated instue-gel was added for foam that placed by ENT surgeon after graft addition |
| placebo group | Placebo comparator | Other: foamempty foam was placed after surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- unfit for general anesthesia,
- had cervical spine disorders limiting operative positioning,
- active otorrhea, granulation tissue, or mucosal inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin (Humulin)insulin was formulated as insitu gel | Drug | insulin insitu gel |
| foamPlain foam | Other | placebo group |
Primary outcome
Perforation size
Time frame: 1 month
endoscopic otoscopy, with graft uptake classified as complete, partial, or failed/reperforated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Insulin (Humulin) and foam in people with Tympanic Membrane Perforation, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perforation size (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.