ApitoxinNCT07135609
Apitoxin Versus Soft Laser for Management of Aphthous Ulceration.
A study testing Low-level laser therapy (LLLT) and Apitoxin in people with Apitoxin and Bee Venom Therapy, run by Tanta University at 1 site in Egypt.
Trial summary
The current study evaluated the clinical effect and outcome of locally applied bee venom versus low-level laser therapy (LLLT) for the treatment of recurrent aphthous ulceration. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Apitoxin, Bee Venom Therapy, Management
- What is being tested?
- Low-level laser therapy (LLLT) and Apitoxin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2024to 2 Feb 2025
- Phase
- Interventional
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age from 15 to 40 years old.
- Both sexes.
- No current or history of systemic medical problem.
- Non-smoker.
- Suffering from pain due to recurrent aphthous stomatitis (RAS) ulceration on the oral mucosa with the following characteristics:
- Duration of 2 days or less.
- The diameter ≥ 4mm
- Not been subjected to any treatment modalities for at least four weeks before the beginning of the study.
Who cannot join
- Presence of other oral mucosal ulcers other than RAS.
- Systemic disease that predisposed them to RAS (e.g., Behçet disease).
- Systemic medical problems.
- Pregnant, lactating, and postmenopausal patients.
- Smoker patients.
- Systemic or topical treatment for RAS less than four weeks before starting the study.
- Any earlier experiences of laser therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Apitoxin Versus Soft Laser for Management of Aphthous Ulceration
The current study evaluated the clinical effect and outcome of locally applied bee venom versus low-level laser therapy (LLLT) for the treatment of recurrent aphthous ulceration.
Read the detailed description
Recurrent aphthous stomatitis (RAS) is a Painful, idiopathic, and recurrent inflammatory ulceration of the oral cavity.
Despite their widespread use, prolonged or frequent application may result in adverse effects such as oral candida. In recent years, low-level laser therapy (LLLT) has gained attention as an alternative treatment for RAS.
Apitoxin has been used traditionally to treat a variety of conditions, such as arthritis, rheumatism, back pain, cancer, and skin diseases.
- Conditions
- Apitoxin, Bee Venom Therapy, Management, Aphthous Ulceration
- Being tested
- Low-level laser therapy (LLLT), Apitoxin
- Medical subject headings
- Foot-and-Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapy (LLLT)Device
Patients managed by Low-level laser therapy (LLLT).
ApitoxinDrug
Patients managed with 0.3% Apitoxin Gel.
| Study group | Role | What they receive |
|---|---|---|
| Group Ӏ | Active comparator | Patients managed by Low-level laser therapy (LLLT). Receives: Device: Low-level laser therapy (LLLT) |
| Group II | Experimental | Patients managed with 0.3% Apitoxin Gel. Receives: Drug: Apitoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Surface Area
Ulcer Surface Area: The main outcome will be the objective measurement of the ulcer surface area. This was evaluated through photographs taken on Day 1 (baseline) and Day 5 (post-treatment).
Measured: 5 days post-treatment
Secondary outcomes (2)
Pain Sensation
Subjective evaluation of pain sensation using the Visual Analog Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). Pain will be assessed on Day 1 (baseline) and Day 5 (post-treatment).
Measured: 5 days post-treatment
Effectiveness Index (EI)
Calculated improvement in pain sensation for each patient based on baseline and post-treatment Visual Analog Scale (VAS). Formula: (VAS baseline - VAS post-treatment) / VAS baseline × 100%
Measured: 5 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start30 Apr 2024
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ApitoxinStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Omar Elboraey Elbal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135609
- Sponsor's protocol ID
- TUCDREC/300424/ Rsabra.
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Elboraey MO, Mohamed Gamal SM, Sabra RS, Fayad MI, Alqhtani A, Meer R. A comparative study of the efficacy of apitoxin gel versus photobiomodulation by diode laser for recurrent aphthous stomatitis treatment. J Taibah Univ Med Sci. 2026 Oct 1;21(5):1056-1066. doi: 10.1016/j.jtumed.2026.09.007. eCollection 2026 Oct.
PubMed 42866728
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apitoxin Versus Soft Laser for Management of Aphthous Ulceration
- ClinicalTrials.gov ID
- NCT07135609
- Acronym / sponsor ID
- TUCDREC/300424/ Rsabra.
- Conditions
- Apitoxin, Bee Venom Therapy, Management, Aphthous Ulceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 22 Aug 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.
The current study evaluated the clinical effect and outcome of locally applied bee venom versus low-level laser therapy (LLLT) for the treatment of recurrent aphthous ulceration.
Detailed description
Recurrent aphthous stomatitis (RAS) is a Painful, idiopathic, and recurrent inflammatory ulceration of the oral cavity.
Despite their widespread use, prolonged or frequent application may result in adverse effects such as oral candida. In recent years, low-level laser therapy (LLLT) has gained attention as an alternative treatment for RAS.
Apitoxin has been used traditionally to treat a variety of conditions, such as arthritis, rheumatism, back pain, cancer, and skin diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Ӏ | Active comparator | Device: Low-level laser therapy (LLLT)Patients managed by Low-level laser therapy (LLLT). |
| Group II | Experimental | Drug: ApitoxinPatients managed with 0.3% Apitoxin Gel. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age from 15 to 40 years old.
- Both sexes.
- No current or history of systemic medical problem.
- Non-smoker.
- Suffering from pain due to recurrent aphthous stomatitis (RAS) ulceration on the oral mucosa with the following characteristics:
Key exclusion criteria (7 listed)
- Presence of other oral mucosal ulcers other than RAS.
- Systemic disease that predisposed them to RAS (e.g., Behçet disease).
- Systemic medical problems.
- Pregnant, lactating, and postmenopausal patients.
- Smoker patients.
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 |
|---|---|---|
| Low-level laser therapy (LLLT)Patients managed by Low-level laser therapy (LLLT). | Device | Group Ӏ |
| ApitoxinPatients managed with 0.3% Apitoxin Gel. | Drug | Group II |
Primary outcome
Ulcer Surface Area
Time frame: 5 days post-treatment
Ulcer Surface Area: The main outcome will be the objective measurement of the ulcer surface area. This was evaluated through photographs taken on Day 1 (baseline) and Day 5 (post-treatment).
2 secondary outcomes
Pain Sensation
Time frame: 5 days post-treatment
Effectiveness Index (EI)
Time frame: 5 days post-treatment
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 22 Aug 2025.
- Derived from this study: PubMed 42866728Elboraey MO, Mohamed Gamal SM, Sabra RS, Fayad MI, Alqhtani A, Meer R. A comparative study of the efficacy of apitoxin gel versus photobiomodulation by diode laser for recurrent aphthous stomatitis treatment. J Taibah Univ Med Sci. 2026 Oct 1;21(5):1056-1066. doi: 10.1016/j.jtumed.2026.09.007. eCollection 2026 Oct.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Apitoxin
RecruitingObservational study
Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure
Bee Venom Allergy
Not yet recruiting
Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis:
Chronic Sinusitis, Acute Sinusitis
Not yet recruiting
Phonophoresis With Bee Venom: Evaluating Its Efficacy in Managing Pain and Enhancing Mobility in Knee Osteoarthritis Patients
Knee Osteoarthritis, Osteoarthritis
Not yet recruiting
Virtual-reality Induced Immune Modulation in Allergic Patients
Hymenoptera Venom Allergy
Not yet recruitingPhase 1/2
Effect of Bee Venom on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Randomized Controlled Trial
Chronic Kidney Disease, Bee Venom
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 study testing Low-level laser therapy (LLLT) and Apitoxin in people with Apitoxin and Bee Venom Therapy, run by Tanta 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 8 inclusion and 7 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 22 Aug 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.
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?
Ulcer Surface Area (time frame: 5 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07135609, which also lists 1 linked publication.
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 22 Aug 2025.