- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531472
Outcome of Hyaluronic Acid Gel Versus Petroleum Jelly in Treatment of Epistaxis
April 18, 2026 updated by: Marina Emil Kamal Kaml, Assiut University
The aim of this study is to compare the efficacy of Hyaluronic Acid Gel with Petroleum Jelly in treatment of epistaxis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
- Epistaxis is one of the most common otorhinolaryngologic emergencies. It affects up to 60% of the population during their lifetime, with 6% requiring medical attention. The greatest peaks in the overall incidence occur in individuals under 10 years of age and over 40 years of age.
- In 1879, James Little identified an arterial plexus on the anterior septum as a frequent site of bleeding and the same plexus was described one year later by Kiesselbach. As a result of these descriptions, the area most frequently implicated in epistaxis is known as Little's area or Kiesselbach plexus which is anatomically formed by the anastomosis between the terminal branches of the external and internal carotid arteries (Anterior ethmoidal artery, Septal branch of Superior labial artery, Septal branch of Sphenopalatine artery, Septal branch of Greater palatine artery) .
- The most common etiology of epistaxis is idiopathic in 80%-90% of cases, no precipitating causes can be identified. Of the other identifiable local causes of epistaxis, the most frequent are trauma, nasal neoplasm, iatrogenic or due to systemic factors (hypertension, coagulopathy, inflammatory conditions, infectious diseases, vessel wall fibrosis in associated with ageing), use of drugs (anticoagulant, antiplatelet, nonsteroidal anti-inflammatory nasal sprays) and congenital nasal septal abnormalities .
- Management of recurrent anterior epistaxis can be done by cautery (chemical or electrical), anterior nasal packing or Surgical therapy if the other methods failed .
- This protocol outlines standardized guidelines for the use of Hyaluronic Acid (HA) in epistaxis management for nasal mucosal hydration, healing, and recurrence prevention. It is suitable for use in ENT clinics, emergency departments, and hospital wards.
Mechanism of action of Hyaluronic acid:
- Hydration: Binds large amounts of water, maintaining skin moisture and elasticity.
- Wound healing: Promotes keratinocyte and fibroblast proliferation, enhancing tissue repair and regeneration.
- Anti-inflammatory effect: Reduces inflammatory cytokines and modulates immune response.
- Barrier protection: Forms a protective layer that prevents water loss and protects against irritants and microbes.
- Collagen stimulation: Supports collagen synthesis and improves skin structure.
- Antioxidant action: Scavenges free radicals, reducing oxidative damage.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marina Emil Kamal Kaml, M.B.B.CH
- Phone Number: +201274047194
- Email: Mareena.20134245@med.aun.edu.eg
Study Contact Backup
- Name: Ahmed Ragab Sayed, Lecturer
- Phone Number: +201099924177
- Email: ahmedsayed12345@aun.edu.eg
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with anterior localized idiopathic epistaxis
Exclusion Criteria:
- Patients wit secondary epistaxis (posttraumatic, postoperative, tumoral).
- During pregnancy.
- Patients wit major systemic disease (Blood Disease, Hypertension).
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hyaluronic Acid Gel
"Participants in this group will receive topical hyaluronic acid gel applied to the nasal mucosa for the treatment of epistaxis.
The application will be done as per the study protocol, and outcomes will be monitored over the study period."
|
"Topical hyaluronic acid gel will be applied to the nasal mucosa of participants for the treatment of epistaxis.
The gel will be administered according to the study protocol and frequency, and outcomes will be assessed throughout the study period."
|
|
Experimental: Petroleum Jelly
"Participants in this group will receive topical petroleum jelly applied to the nasal mucosa for the treatment of epistaxis.
The application will follow the study protocol, and outcomes will be monitored over the study period."
|
"Topical petroleum jelly will be applied to the nasal mucosa of participants for the treatment of epistaxis.
The application will follow the study protocol, and outcomes will be monitored and recorded over the study period."
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the recurrence rate of epistaxis between the two groups
Time Frame: 14 days
|
"Proportion of participants whose epistaxis stops completely within 7 days of treatment application."
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess time to symptom resolution
Time Frame: Within 24 hours
|
"Time in minutes or hours from first application to complete cessation of nasal bleeding."
|
Within 24 hours
|
|
To evaluate mucosal healing (endoscopic findings)
Time Frame: 7-14 days
|
"Assessment of nasal mucosa healing using endoscopic examination after application of hyaluronic acid gel or petroleum jelly, scored according to a standardized mucosal healing scale."
|
7-14 days
|
|
To assess patient comfort and compliance
Time Frame: 7 days
|
"Measured using a standardized questionnaire or visual analog scale during the treatment period."
|
7 days
|
|
To record adverse effects
Time Frame: 14 days
|
"Incidence of local irritation, allergic reactions, or other side effects related to the topical intervention."
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ahmed AbdelAleem AbdelWahab, Prof
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (Estimated)
May 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
April 9, 2026
First Submitted That Met QC Criteria
April 9, 2026
First Posted (Actual)
April 15, 2026
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 18, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAvsPJ-EPI
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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