BurnEarly Phase 1NCT07149844
Healing Effect of Tea Tree Oil on Burn
A Early Phase 1 study testing tea tree oil ointment in people with Burn, run by Alexandria University at 1 site in Egypt.
Trial summary
Tea tree oil (TTO) has been recognized for its effectiveness in treating infected burns, insect bites, and promoting wound healing. This clinical study aimed to compare the impact of Tea tree oil dressings versus conventional ones in the healing process of second degree burns wounds. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn
- What is being tested?
- tea tree oil ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2021to 22 Sep 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient willing to participate and communicate
- Newly admitted with recent 2nd-degree burns (superficial or deep) involving ≤10% of TBSA
- Length of hospital stay of 10 days
Who cannot join
- Any associated illnesses that may affect wound healing, such as:
- Diabetes mellitus (DM)
- Immune disorders
- Pre-existing skin conditions (e.g., eczema)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of Tea Tree Oil (Melaleuca Alternifolia) and Conventional Topical Dressing on Healing of Second-Degree Burn Wounds
Tea tree oil (TTO) has been recognized for its effectiveness in treating infected burns, insect bites, and promoting wound healing. This clinical study aimed to compare the impact of Tea tree oil dressings versus conventional ones in the healing process of second degree burns wounds.
Read the detailed description
This quasi-experimental comparative controlled clinical trial was conducted at the Burn Unit of Ras-Elteen General Hospital in Alexandria, Egypt. A purposive sample of 30 adult patients with second-degree burns on the chest, abdomen, upper limbs (excluding hands), and lower limbs (excluding feet) was enrolled from the Emergency and Outpatient Departments. Participants were sequentially assigned to two equal groups:
Control group (n=15): Received conventional dressings (sterile gauze with silver sulfadiazine).
Study group (n=15): Received topical 10% tea tree oil (TTO) ointment applied directly to wounds.Wounds were cleansed with sterile normal saline (0.9%), and non-viable tissue was debrided.
Dressings were changed every other day unless soiled or damp. Burns near joints were maintained in functional positions.Wound assessment was performed on days 7, 14, and 21 post-treatment
- Conditions
- Burn
- Being tested
- tea tree oil ointment
- Keywords
- Burn, Tea Tree Oil
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tea tree oil ointmentDrug
Also called فtea tree ointment
Petrolatum (petroleum jelly) was sterilized in the oven at 160°C for 90 min, then The ointment was prepared as 10% .
| Study group | Role | What they receive |
|---|---|---|
| conventional dressing | Other | Conventional dressing: Is the routine study hospital's burn dressing technique, utilizing sterile topical gauze dressing that is impregnated with or laid over a topical antibacterial, silver sulphadiazin dressing secured with adhesive tape. Receives: Drug: tea tree oil ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphological wound changes
assessment of: wound bed, wound margin: color, size, depth, presence of exudates: its amount, color, odor, and type, or scare, edema and granulation tissue formation; in addition to assessment of the wound's surrounding skin condition for: erythema, hotness, tenderness, swelling, separation of deep tissues, fever and peri-wound skin laceration. Each item was rated to score on 2 points Likert scale: 0 = not present and 1= Present.
A total score of every patient in both groups was summed up and converted into percent score. to desribe wound healing process as ; complete healing: ; Partial healing: and No healing: where higher percent represent better healing
Measured: 3 weeks
Local infection scoring system
Local infection scoring system was recorded as: 0= Absence of infection. 1= Presence of local signs of wound infection (redness, hotness, tenderness, purulent discharge and swelling)2 = Presence of systemic wound infection signs (fever, elevated WBCs, ESR and elevated CRP)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start2 Jul 2021
- Primary completion22 Jul 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hoda fathy, prof, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149844
- Sponsor's protocol ID
- 1482025
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data can be shared on researchgate or other official database
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Tea Tree Oil (Melaleuca Alternifolia) and Conventional Topical Dressing on Healing of Second-Degree Burn Wounds
- ClinicalTrials.gov ID
- NCT07149844
- Acronym / sponsor ID
- 1482025
- Conditions
- Burn
- Keywords
- Burn, Tea Tree Oil
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 2 Sep 2025 (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.
Tea tree oil (TTO) has been recognized for its effectiveness in treating infected burns, insect bites, and promoting wound healing. This clinical study aimed to compare the impact of Tea tree oil dressings versus conventional ones in the healing process of second degree burns wounds.
Detailed description
This quasi-experimental comparative controlled clinical trial was conducted at the Burn Unit of Ras-Elteen General Hospital in Alexandria, Egypt. A purposive sample of 30 adult patients with second-degree burns on the chest, abdomen, upper limbs (excluding hands), and lower limbs (excluding feet) was enrolled from the Emergency and Outpatient Departments. Participants were sequentially assigned to two equal groups:
Control group (n=15): Received conventional dressings (sterile gauze with silver sulfadiazine).
Study group (n=15): Received topical 10% tea tree oil (TTO) ointment applied directly to wounds.Wounds were cleansed with sterile normal saline (0.9%), and non-viable tissue was debrided.
Dressings were changed every other day unless soiled or damp. Burns near joints were maintained in functional positions.Wound assessment was performed on days 7, 14, and 21 post-treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| conventional dressing | Other | Drug: tea tree oil ointmentConventional dressing: Is the routine study hospital's burn dressing technique, utilizing sterile topical gauze dressing that is impregnated with or laid over a topical antibacterial, silver sulphadiazin dressing secured with adhesive tape. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient willing to participate and communicate
- Newly admitted with recent 2nd-degree burns (superficial or deep) involving ≤10% of TBSA
- Length of hospital stay of 10 days
Key exclusion criteria (4 listed)
- Diabetes mellitus (DM)
- Immune disorders
- Pre-existing skin conditions (e.g., eczema)
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 |
|---|---|---|
| tea tree oil ointmentAlso: فtea tree ointmentPetrolatum (petroleum jelly) was sterilized in the oven at 160°C for 90 min, then The ointment was prepared as 10% . | Drug | conventional dressing |
Primary outcome
morphological wound changes
Time frame: 3 weeks
assessment of: wound bed, wound margin: color, size, depth, presence of exudates: its amount, color, odor, and type, or scare, edema and granulation tissue formation; in addition to assessment of the wound's surrounding skin condition for: erythema, hotness, tenderness, swelling, separation of deep tissues, fever and peri-wound skin laceration. Each item was rated to score on 2 points Likert scale: 0 = not present and 1= Present. A total score of every patient in both groups was summed up and converted into percent score. to desribe wound healing process as ; complete healing: ; Partial healing: and No healing: where higher percent represent better healing
Local infection scoring system
Time frame: 3 weeks
Local infection scoring system was recorded as: 0= Absence of infection. 1= Presence of local signs of wound infection (redness, hotness, tenderness, purulent discharge and swelling)2 = Presence of systemic wound infection signs (fever, elevated WBCs, ESR and elevated CRP)
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 12 Sep 2025.
- Individual participant dataSharing planned: Yes. data can be shared on researchgate or other official database
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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.
hoda fathy, prof principal investigator
Alexandria University
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 tea tree oil ointment in people with Burn, run by Alexandria 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 3 inclusion and 4 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 12 Sep 2025. 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. 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?
morphological wound changes (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 12 Sep 2025.