Erosive Oral Lichen PlanusPhase 2NCT06988527
Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
A Phase 2 study testing Honey in orabase 1: 1 paste in people with Erosive Oral Lichen Planus and Atrophic Lichen Planus, run by Dar Al Uloom University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to assess Honey in orabase (1:1) for treating patients with OLP and improving their quality of life: The research question aims to answer: Does honey in orabase (1:1) improve or reduce OLP symptoms compared to the standardized treatment by triamcinolone acetonide 0.1% drug and… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Erosive Oral Lichen Planus, Atrophic Lichen Planus
- What is being tested?
- Honey in orabase 1: 1 paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 May 2025to 15 Jun 2026
- Phase
- Phase 2
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a clinical diagnosis of oral lichen planus
- Symptomatic OLP lesions (erosive/atrophic)
- Participants are between 35 and 60 years old, who are able to adhere to the study protocol, and sign informed consent.
Who cannot join
- Patients with other oral mucosal disorders, or systemic conditions influencing OLP or wound healing, allergies or hypersensitivity to honey or triamcinolone
- Patients who administer systemic corticosteroids or immunosuppressive agents.
- Pregnancy or lactation
- Inability to comprehend or adhere to study directives
- Patients who are not able to sign an informed written consent
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to assess Honey in orabase (1:1) for treating patients with OLP and improving their quality of life:
The research question aims to answer:
Does honey in orabase (1:1) improve or reduce OLP symptoms compared to the standardized treatment by triamcinolone acetonide 0.1% drug and improve the patient's quality of life?
Participants will:
Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Read the detailed description
The study comprised 56 patients diagnosed with Oral Lichen Planus, who were randomly selected according to inclusion and exclusion criteria. The subjects were between 35 and 60 years old, capable of complying with the study procedure, and provided informed consent. Exclusion criteria encompassed those with alternative oral mucosal illnesses, systemic problems influencing OLP or wound healing, allergies or sensitivities to honey or triamcinolone, or those receiving systemic corticosteroids or immunosuppressive drugs. Individuals who were pregnant or lactating, as well as those unable to provide informed written consent, were excluded.
- Conditions
- Erosive Oral Lichen Planus, Atrophic Lichen Planus
- Being tested
- Honey in orabase 1: 1 paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey in orabase 1: 1 pasteDrug
Also called Triamcinolone acetonide 0.1% ointment
The experimental drug was manufactured and packed at the Faculty of Pharmacy, Price Sattam University, SA. Production of a mucoadhesive paste involves a step-by-step process. in the final step, honey, comprising 50% of the total composition was thoroughly blended with the prepared base to ensure homogeneity
| Study group | Role | What they receive |
|---|---|---|
| Group I with OLP at buccal mucosa | Experimental | The trial Group (I) (honey in orabase 1: 1 paste), four times daily after meals or rinsing Receives: Drug: Honey in orabase 1: 1 paste |
| Group II with OLP at buccal mucosa | Active comparator | Group (II): triamcinolone acetonide 0.1% ointment, four times daily after meals or rinsing Receives: Drug: Honey in orabase 1: 1 paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment of OLP lesions using OLP score
will be assessed by OLP score: Thongprasom et al.: score 0 (no lesions), score 1 (mild white striae only with no erythematous areas), score 2 (white striae exhibiting an atrophic area < 1 cm2), score 3 (white striae alongside an atrophic area ≥ 1 cm2), score 4 (white striae in an erosive area < 1 cm2), and score 5 (white striae alongside an erosive area ≥1 cm2). Atrophic OLP was defined as thinning of the oral mucosa, with a smooth red appearance, while erosive OLP involved ulceration and erosion of the mucosal surface.
Measured: baseline to 1 year
Pain assessment using Visual analogue scale (VAS)
(VAS) is a self-reported score typically consisting of a 10 cm horizontal line from right (best) to left (worst) with verbal descriptions (word anchors: 0 cm: No pain; 1 cm: Hardly notice pain; 2 cm: Notice pain does not interfere with activities; 3 cm: Sometimes distracts me; 4 cm: Distracts me, can do usual activities; 5 cm: Interrupts some activities; 6 cm: Hard to ignore, avoid usual activities; 7 cm: focus of attention, prevent doing daily activities; 8 cm: Awful, hard to do anything; 9 cm: Can not bear the pain, unable to do anything; 10 cm: As bad as it could be, nothing else matters)
Measured: baseline- to 1 year
Secondary outcomes (1)
Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment
Patient Satisfaction: Measured using a Likert scale questionnaire (e.g., 1-5, where 1 = very dissatisfied and 5 = very satisfied).
Recurrence % or Complications
Quality of Life: Reassess by using OHIP-14 at each follow-up.
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start20 May 2025
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Oral Lichen PlanusStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Zα/2=1.96=1.96 (for 95% confidence) * Zβ=1.28 (to 90% power) * SD=196 * Δ=1.33 N≈55.65 N=56 56 patients diagnosed with Oral Lichen Planus, randomly assigned to one of the 2 groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar Al Uloom University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Abd-ElMeniem ElHaddad, Dar Al Uloom University
- Investigators
- Sally A ElHaddad, Assist. Prof, Principal investigator, Dar AlUloom University, SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988527
- Sponsor's protocol ID
- 010-012-2022
- Status last verified
- Aug 2026
- First submitted
- 16 May 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be made available to researchers upon reasonable request, in order to support further research and meta-analyses. Data to be Shared: Demographic data (e.g., age, gender) Baseline clinical characteristics Treatment allocation (coded) Outcome measures (e.g., clinical response, pain scores, lesion size) Adverse events and safety data Follow-up assessments Supporting Documents: Study protocol Statistical analysis plan Informed consent form (redacted) Case report forms (CRFs)
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
- ClinicalTrials.gov ID
- NCT06988527
- Acronym / sponsor ID
- 010-012-2022
- Conditions
- Erosive Oral Lichen Planus, Atrophic Lichen Planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Dar Al Uloom UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 25 May 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 goal of this clinical trial is to assess Honey in orabase (1:1) for treating patients with OLP and improving their quality of life:
The research question aims to answer:
Does honey in orabase (1:1) improve or reduce OLP symptoms compared to the standardized treatment by triamcinolone acetonide 0.1% drug and improve the patient's quality of life?
Participants will:
Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Detailed description
The study comprised 56 patients diagnosed with Oral Lichen Planus, who were randomly selected according to inclusion and exclusion criteria. The subjects were between 35 and 60 years old, capable of complying with the study procedure, and provided informed consent. Exclusion criteria encompassed those with alternative oral mucosal illnesses, systemic problems influencing OLP or wound healing, allergies or sensitivities to honey or triamcinolone, or those receiving systemic corticosteroids or immunosuppressive drugs. Individuals who were pregnant or lactating, as well as those unable to provide informed written consent, were excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * Zα/2=1.96=1.96 (for 95% confidence) * Zβ=1.28 (to 90% power) * SD=196 * Δ=1.33 N≈55.65 N=56 56 patients diagnosed with Oral Lichen Planus, randomly assigned to one of the 2 groups
| Arm | Type | Receives |
|---|---|---|
| Group I with OLP at buccal mucosa | Experimental | Drug: Honey in orabase 1: 1 pasteThe trial Group (I) (honey in orabase 1: 1 paste), four times daily after meals or rinsing |
| Group II with OLP at buccal mucosa | Active comparator | Drug: Honey in orabase 1: 1 pasteGroup (II): triamcinolone acetonide 0.1% ointment, four times daily after meals or rinsing |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with a clinical diagnosis of oral lichen planus
- Symptomatic OLP lesions (erosive/atrophic)
- Participants are between 35 and 60 years old, who are able to adhere to the study protocol, and sign informed consent.
Key exclusion criteria (5 listed)
- Patients with other oral mucosal disorders, or systemic conditions influencing OLP or wound healing, allergies or hypersensitivity to honey or triamcinolone
- Patients who administer systemic corticosteroids or immunosuppressive agents.
- Pregnancy or lactation
- Inability to comprehend or adhere to study directives
- Patients who are not able to sign an informed written consent
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 |
|---|---|---|
| Honey in orabase 1: 1 pasteAlso: Triamcinolone acetonide 0.1% ointmentThe experimental drug was manufactured and packed at the Faculty of Pharmacy, Price Sattam University, SA. Production of a mucoadhesive paste involves a step-by-step process. in the final step, honey, comprising 50% of the total composition was thoroughly blended with the prepared base to ensure homogeneity | Drug | Group I with OLP at buccal mucosa, Group II with OLP at buccal mucosa |
Primary outcome
Clinical Assessment of OLP lesions using OLP score
Time frame: baseline to 1 year
will be assessed by OLP score: Thongprasom et al.: score 0 (no lesions), score 1 (mild white striae only with no erythematous areas), score 2 (white striae exhibiting an atrophic area < 1 cm2), score 3 (white striae alongside an atrophic area ≥ 1 cm2), score 4 (white striae in an erosive area < 1 cm2), and score 5 (white striae alongside an erosive area ≥1 cm2). Atrophic OLP was defined as thinning of the oral mucosa, with a smooth red appearance, while erosive OLP involved ulceration and erosion of the mucosal surface.
Pain assessment using Visual analogue scale (VAS)
Time frame: baseline- to 1 year
(VAS) is a self-reported score typically consisting of a 10 cm horizontal line from right (best) to left (worst) with verbal descriptions (word anchors: 0 cm: No pain; 1 cm: Hardly notice pain; 2 cm: Notice pain does not interfere with activities; 3 cm: Sometimes distracts me; 4 cm: Distracts me, can do usual activities; 5 cm: Interrupts some activities; 6 cm: Hard to ignore, avoid usual activities; 7 cm: focus of attention, prevent doing daily activities; 8 cm: Awful, hard to do anything; 9 cm: Can not bear the pain, unable to do anything; 10 cm: As bad as it could be, nothing else matters)
1 secondary outcome
Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment
Time frame: baseline to 1 year
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 27 Aug 2026.
- Individual participant dataSharing planned: Yes. will be made available to researchers upon reasonable request, in order to support further research and meta-analyses. Data to be Shared: Demographic data (e.g., age, gender) Baseline clinical characteristics Treatment allocation (coded) Outcome measures (e.g., clinical response, pain scores, lesion size) Adverse events and safety data Follow-up assessments Supporting Documents: Study protocol Statistical analysis plan Informed consent form (redacted) Case report forms (CRFs)
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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.
Sally A ElHaddad, Assist. Prof principal investigator
Dar AlUloom University, SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Honey in orabase 1: 1 paste in people with Erosive Oral Lichen Planus and Atrophic Lichen Planus, run by Dar Al Uloom University at 1 site in Saudi Arabia.
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 5 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 27 Aug 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 Saudi Arabia. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical Assessment of OLP lesions using OLP score (time frame: baseline to 1 year). 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 27 Aug 2026.