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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

    1. Hydration: Binds large amounts of water, maintaining skin moisture and elasticity.
    2. Wound healing: Promotes keratinocyte and fibroblast proliferation, enhancing tissue repair and regeneration.
    3. Anti-inflammatory effect: Reduces inflammatory cytokines and modulates immune response.
    4. Barrier protection: Forms a protective layer that prevents water loss and protects against irritants and microbes.
    5. Collagen stimulation: Supports collagen synthesis and improves skin structure.
    6. Antioxidant action: Scavenges free radicals, reducing oxidative damage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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."
Drug: Hyaluronic Acid Gel
"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."
Drug: Petroleum jelly
"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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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