Lichen Planus, OralPhase 4RCTNCT06362005
The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus
A Phase 4 study testing Triamcinolone Acetonide 0.1% Oint, Tacrollimus Topical and Selenium in people with Lichen Planus, Oral, run by Al-Azhar University at 1 site in Egypt.
Trial summary
evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Lichen Planus, Oral
- What is being tested?
- Triamcinolone Acetonide 0.1% Oint, Tacrollimus Topical and Selenium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Oct 2025
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of OLP
Who cannot join
- lichenoid reaction from medication ' .
- any systemic autoimmune disease
- Pregnancy
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (Randomized Clinical Trial)
evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.
Read the detailed description
The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .
- Conditions
- Lichen Planus, Oral
- Being tested
- Triamcinolone Acetonide 0.1% Oint, Tacrollimus Topical, Selenium, Selenium & Triamcinolone Acetonide 0.1% Oint, Selenium& Tacrollimus topical
- Keywords
- seleinum, Antioxidant, Glutathione-S-transferases, Reactive oxygen species
- 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.
Triamcinolone Acetonide 0.1% OintDrug
Also called Group I
RCT
Tacrollimus TopicalDrug
Also called Group II
RCT
SeleniumDrug
Also called Group III
RCT
Selenium & Triamcinolone Acetonide 0.1% OintDrug
Also called Group IV
RCT
Selenium& Tacrollimus topicalDrug
Also called Group V
RCT
| Study group | Role | What they receive |
|---|---|---|
| group I (triamcinolone) | Placebo comparator | ten patients with oral lichen planus, will receive topical triamcinolone acetonide 0.1% four times per day for six weeks. Receives: Drug: Triamcinolone Acetonide 0.1% Oint |
| group II (tacrollimus) | Placebo comparator | ten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks. Receives: Drug: Tacrollimus Topical |
| group III (selenium) | Experimental | ten patients with oral lichen planus, will receive topical selenium four times per day for six weeks. Receives: Drug: Selenium |
| group IV (selenium + triamcinolone ) | Experimental | : ten patients with oral lichen planus, will receive topical selenium combined with topical triamcinolone acetonide 0.1% three times per day for each for six weeks Receives: Drug: Selenium & Triamcinolone Acetonide 0.1% Oint |
| group V ( selenium + tacrollimus) | Experimental | ten patients with oral lichen planus, will receive topical selenium combined with topical tacrolimus 0.1% three times per day for each for six weeks. Receives: Drug: Selenium& Tacrollimus topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess a visual analog scale (VAS)of the oral lichen planus lesion
qualitative
Measured: baseline, 1, 3 and 6 months after treatment
Secondary outcomes (2)
to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis
qualitative ,and quantitiave
Measured: baseline, 1, 3 and 6 months after treatment
Biochemical evaluation of salivary Glutathione level using (ELISA)
Quantity
Measured: baseline, 1, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 May 2024
- Primary completion1 Jul 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Planus, OralStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Sphinx university
- Responsible party
- Principal investigator, Shaymaa Hussein Rafat Kotb, Sphinx university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362005
- Sponsor's protocol ID
- AUAREC2023011-1
- Acronym
- RCT
- Status last verified
- Dec 2025
- First submitted
- 27 Mar 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patients were recruited from the outpatient clinic of the Dermatology Department, Assiut University Hospitals, and referred to oral Medicine clinics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06362005
- Acronym / sponsor ID
- RCT / AUAREC2023011-1
- Conditions
- Lichen Planus, Oral
- Keywords
- seleinum, Antioxidant, Glutathione-S-transferases, Reactive oxygen species
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Sphinx university
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 12 Apr 2024 (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.
evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.
Detailed description
The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| group I (triamcinolone) | Placebo comparator | Drug: Triamcinolone Acetonide 0.1% Ointten patients with oral lichen planus, will receive topical triamcinolone acetonide 0.1% four times per day for six weeks. |
| group II (tacrollimus) | Placebo comparator | Drug: Tacrollimus Topicalten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks. |
| group III (selenium) | Experimental | Drug: Seleniumten patients with oral lichen planus, will receive topical selenium four times per day for six weeks. |
| group IV (selenium + triamcinolone ) | Experimental | Drug: Selenium & Triamcinolone Acetonide 0.1% Oint: ten patients with oral lichen planus, will receive topical selenium combined with topical triamcinolone acetonide 0.1% three times per day for each for six weeks |
| group V ( selenium + tacrollimus) | Experimental | Drug: Selenium& Tacrollimus topicalten patients with oral lichen planus, will receive topical selenium combined with topical tacrolimus 0.1% three times per day for each for six weeks. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- clinical diagnosis of OLP
Key exclusion criteria (4 listed)
- lichenoid reaction from medication ' .
- any systemic autoimmune disease
- Pregnancy
- smokers
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 |
|---|---|---|
| Triamcinolone Acetonide 0.1% OintAlso: Group IRCT | Drug | group I (triamcinolone) |
| Tacrollimus TopicalAlso: Group IIRCT | Drug | group II (tacrollimus) |
| SeleniumAlso: Group IIIRCT | Drug | group III (selenium) |
| Selenium & Triamcinolone Acetonide 0.1% OintAlso: Group IVRCT | Drug | group IV (selenium + triamcinolone ) |
| Selenium& Tacrollimus topicalAlso: Group VRCT | Drug | group V ( selenium + tacrollimus) |
Primary outcome
to assess a visual analog scale (VAS)of the oral lichen planus lesion
Time frame: baseline, 1, 3 and 6 months after treatment
qualitative
2 secondary outcomes
to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis
Time frame: baseline, 1, 3 and 6 months after treatment
Biochemical evaluation of salivary Glutathione level using (ELISA)
Time frame: baseline, 1, 3 months after 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 31 Dec 2025.
- orcidLink provided by the sponsor.
- ncbiLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All patients were recruited from the outpatient clinic of the Dermatology Department, Assiut University Hospitals, and referred to oral Medicine clinics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.
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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 4 study testing Triamcinolone Acetonide 0.1% Oint, Tacrollimus Topical and Selenium in people with Lichen Planus, Oral, run by Al-Azhar 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 1 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 31 Dec 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
to assess a visual analog scale (VAS)of the oral lichen planus lesion (time frame: baseline, 1, 3 and 6 months after treatment). 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 31 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.