Oral Lichen PlanusPhase 1/2NCT07141446
Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus.
A Phase 1/2 study testing Neem gel and Triamcinolone Acetonide in people with Oral Lichen Planus, run by Goa Dental College at 1 site in India.
Trial summary
The goal of this clinical trial is to learn if Neem works to treat Oral Lichen Planus in adults. It will also learn about the safety of Neem in oral lesions. The main questions it aims to answer are: To compare the efficacy of 1.5% Neem Gel (Azadirachta Indica) versus 0.1% Triamcinolone Acetonide in treatment of Oral… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Neem gel and Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 5 Feb 2023to 28 Feb 2024
- Phase
- Phase 1/2
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with clinical \& histopathological diagnosis of OLP.
- Patient above 20 years of age.
- Patient willing to participate in the study with informed consent.
- Patient with recalcitrant OLP.
Who cannot join
- Patient with known allergic reaction to Triamcinolone Acetonide or Neem.
- Patients with lichenoid lesions.
- Patients with associated cutaneous lesions.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Oral Medicine and radiology, Goa Dental College and Hospital, Bambolim Goa India
Goa, Bambolim, 403202
About this study
Official title: Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus: A Randomized Controlled Trial.
The goal of this clinical trial is to learn if Neem works to treat Oral Lichen Planus in adults. It will also learn about the safety of Neem in oral lesions. The main questions it aims to answer are:
To compare the efficacy of 1.5% Neem Gel (Azadirachta Indica) versus 0.1% Triamcinolone Acetonide in treatment of Oral Lichen Planus (OLP) as a topical treatment modality for patients with OLP,
Read more
Researchers will compare Neem to a corticosteroid (a standard treatment for Oral Lichen Planus) to see if Neem works to treat Oral Lichen Planus.
Participants:
In experimental group were given Neem Gel in Orabase formulations and control group with topical Triamcinolone acetonide oral paste to be used twice every day for 3 months Visit the clinic once every month for checkups.
- Conditions
- Oral Lichen Planus
- Being tested
- Neem gel, Triamcinolone Acetonide
- Keywords
- Oral Lichen Planus, Neem, Triamcinolone acetonide, corticosteroid, clinical trial
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neem gelDrug
1.5% Neem Gel in orabase formulation, twice daily application for 3 months
Triamcinolone AcetonideDrug
0.1% oral paste to be applied twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Neem | Experimental | Not described Receives: Drug: Neem gel |
| Triamcinolone Acetonide | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Burning sensation will be evaluated with Visual Analogue scale
Measured: From enrollment to the end of 3 months
Thongprasom's Score
clinical severity of lesion
Measured: From enrollment to the end of the 3 months
OLP Disease Severity Score
Site, size and severity of lesion
Measured: From enrollment to the end of 3 months
Secondary outcomes (1)
Hospital Anxiety and Depression Scale
Anxiety and depression evaluation among patients
Measured: From Enrollment to the end of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start5 Feb 2023
- Primary completion15 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goa Dental College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Medhana Mangaonker, Goa Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141446
- Sponsor's protocol ID
- GDCH/IEC/I-2024(04)
- Status last verified
- Feb 2025
- First submitted
- 19 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07141446
- Acronym / sponsor ID
- GDCH/IEC/I-2024(04)
- Conditions
- Oral Lichen Planus
- Keywords
- Oral Lichen Planus, Neem, Triamcinolone acetonide, corticosteroid, clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Goa Dental CollegeOther government
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 26 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 goal of this clinical trial is to learn if Neem works to treat Oral Lichen Planus in adults. It will also learn about the safety of Neem in oral lesions. The main questions it aims to answer are:
To compare the efficacy of 1.5% Neem Gel (Azadirachta Indica) versus 0.1% Triamcinolone Acetonide in treatment of Oral Lichen Planus (OLP) as a topical treatment modality for patients with OLP,
Researchers will compare Neem to a corticosteroid (a standard treatment for Oral Lichen Planus) to see if Neem works to treat Oral Lichen Planus.
Participants:
In experimental group were given Neem Gel in Orabase formulations and control group with topical Triamcinolone acetonide oral paste to be used twice every day for 3 months Visit the clinic once every month for checkups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neem | Experimental | Drug: Neem gel |
| Triamcinolone Acetonide | Active comparator | Drug: Triamcinolone Acetonide |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with clinical \& histopathological diagnosis of OLP.
- Patient above 20 years of age.
- Patient willing to participate in the study with informed consent.
- Patient with recalcitrant OLP.
Key exclusion criteria (4 listed)
- Patient with known allergic reaction to Triamcinolone Acetonide or Neem.
- Patients with lichenoid lesions.
- Patients with associated cutaneous lesions.
- Pregnant or lactating females.
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 |
|---|---|---|
| Neem gel1.5% Neem Gel in orabase formulation, twice daily application for 3 months | Drug | Neem |
| Triamcinolone Acetonide0.1% oral paste to be applied twice daily for 3 months | Drug | Triamcinolone Acetonide |
Primary outcome
Visual Analogue Scale
Time frame: From enrollment to the end of 3 months
Burning sensation will be evaluated with Visual Analogue scale
Thongprasom's Score
Time frame: From enrollment to the end of the 3 months
clinical severity of lesion
OLP Disease Severity Score
Time frame: From enrollment to the end of 3 months
Site, size and severity of lesion
1 secondary outcome
Hospital Anxiety and Depression Scale
Time frame: From Enrollment to the end of 3 months
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 3 Sep 2025.
- Individual participant dataSharing planned: No
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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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.
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 Phase 1/2 study testing Neem gel and Triamcinolone Acetonide in people with Oral Lichen Planus, run by Goa Dental College at 1 site in India.
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 4 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 3 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 India. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Visual Analogue Scale (time frame: From enrollment to the end of 3 months). The study lists 3 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 3 Sep 2025.