Oral Lichen PlanusNCT04765267
Micronutrients in Management of Symptomatic Oral Lichen Planus
A study testing Zinc sulphate heptahydrate in people with Oral Lichen Planus, run by Cairo University at 1 site in Egypt.
Trial summary
Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Zinc sulphate heptahydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Sep 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffering from erosive or atrophic OLP
- Patients free from any visible oral lesions other than OLP.
- Patients who agreed to take the supplied interventions.
- Patient who will agree to participate in the study.
- Patients who will accept to sign the informed consent.
Who cannot join
- Patients suffering from any systemic disease.
- Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
- Treatment with any oral topical medications for at least four weeks prior to the study.
- Pregnant and lactating mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial
Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh \& Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.
Read the detailed description
The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.
- Conditions
- Oral Lichen Planus
- Being tested
- Zinc sulphate heptahydrate
- Keywords
- micronutrients, topical corticosteroids
- 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.
Zinc sulphate heptahydrateDietary supplement
Also called Cholecalciferol: vitamin D3 oral solution
Dietary supplements
| Study group | Role | What they receive |
|---|---|---|
| Topical Corticosteroid with Systemic Zinc. | Active comparator | Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma Receives: Dietary Supplement: Zinc sulphate heptahydrate |
| Topical Corticosteroid with Systemic Vitamin D | Active comparator | Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals Receives: Dietary Supplement: Zinc sulphate heptahydrate |
| Topical Corticosteroid | Other | Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm Receives: Dietary Supplement: Zinc sulphate heptahydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Visual analogue scale (0-10)
Measured: baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7
Secondary outcomes (1)
change in clinical improvement
measured using Thongprasom et al. scoring system
Measured: baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Apr 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
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 Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Shousha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765267
- Sponsor's protocol ID
- OMED 3-7-2
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aboushousha A, Kamal Y, Ali S. Supplementary zinc and vitamin D in management of symptomatic oral lichen planus: a three-arm randomized clinical trial. BMC Oral Health. 2025 Jun 2;25(1):872. doi: 10.1186/s12903-025-06173-1.
PubMed 40457259
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04765267
- Acronym / sponsor ID
- OMED 3-7-2
- Conditions
- Oral Lichen Planus
- Keywords
- micronutrients, topical corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 21 Feb 2021 (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.
Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh \& Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.
Detailed description
The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Corticosteroid with Systemic Zinc. | Active comparator | Dietary Supplement: Zinc sulphate heptahydrateOctozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma |
| Topical Corticosteroid with Systemic Vitamin D | Active comparator | Dietary Supplement: Zinc sulphate heptahydrateCholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals |
| Topical Corticosteroid | Other | Dietary Supplement: Zinc sulphate heptahydrateKenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from erosive or atrophic OLP
- Patients free from any visible oral lesions other than OLP.
- Patients who agreed to take the supplied interventions.
- Patient who will agree to participate in the study.
- Patients who will accept to sign the informed consent.
Key exclusion criteria (4 listed)
- Patients suffering from any systemic disease.
- Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
- Treatment with any oral topical medications for at least four weeks prior to the study.
- Pregnant and lactating mothers.
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 |
|---|---|---|
| Zinc sulphate heptahydrateAlso: Cholecalciferol: vitamin D3 oral solutionDietary supplements | Dietary supplement | Topical Corticosteroid, Topical Corticosteroid with Systemic Vitamin D, Topical Corticosteroid with Systemic Zinc. |
Primary outcome
Change in pain intensity
Time frame: baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7
Visual analogue scale (0-10)
1 secondary outcome
change in clinical improvement
Time frame: baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7
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 7 Nov 2023.
- Derived from this study: PubMed 40457259Aboushousha A, Kamal Y, Ali S. Supplementary zinc and vitamin D in management of symptomatic oral lichen planus: a three-arm randomized clinical trial. BMC Oral Health. 2025 Jun 2;25(1):872. doi: 10.1186/s12903-025-06173-1.
- Individual participant dataSharing planned: No
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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 study testing Zinc sulphate heptahydrate in people with Oral Lichen Planus, run by Cairo 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 5 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 7 Nov 2023. 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?
Change in pain intensity (time frame: baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7). 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 NCT04765267, 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 7 Nov 2023.