Oral Lichen PlanusPhase 4NCT06204796
The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level
A Phase 4 study testing vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone and Systemic prednisone in people with Oral Lichen Planus and Vitamin D Deficiency, run by Fayoum University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare between the use of vitamin D supplement in conjunction with systemic steroids versus the use of systemic steroids alone in the management of patients with symptomatic Oral Lichen Planus lesions and the comparison of salivary Interferon gamma levels in both study groups… Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Oral Lichen Planus, Vitamin D Deficiency
- What is being tested?
- vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone and Systemic prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Sep 2023
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Middle-aged patients
- Clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP
- Vitamin D deficiency or insufficiency (≤30 ng/ml)
Who cannot join
- Oral mucosal lesion other than OLP
- Suspected restoration-related reaction
- Active periodontitis
- Patients receiving any topical or systemic medication that may affect SVDL or induce a lichenoid reaction
- Patient having systemic disease based on the detailed questionnaire of the modified Cornell Medical Index
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level: a Randomized Clinical Trial
The goal of this clinical trial is to compare between the use of vitamin D supplement in conjunction with systemic steroids versus the use of systemic steroids alone in the management of patients with symptomatic Oral Lichen Planus lesions and the comparison of salivary Interferon gamma levels in both study groups before and after treatment
Read the detailed description
The objective of the research:
To investigate the role of vitamin D supplements in the management of vitamin D deficient oral lichen planus (OLP) patients and to examine its suppressive effect on pro-inflammatory cytokine (IFN-γ) in saliva samples of OLP patients
- Steps in short
1- Trial design: This study is a randomized clinical trial (RCT) having parallel groups with a 1:1 allocation ratio. This study will conform with the Consolidated Standards of Reporting Trials guidelines (CONSORT guidelines).
Middle-aged patients presenting with clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP (32) and having vitamin D deficiency or insufficiency (≤30 ng/ml) (33) will be included in the present study.
4-Intervention and study groups A total of 40 participants will be randomly and equally allocated into one of the two study groups to receive either, systemic steroids and vitamin D supplement (intervention) or systemic steroids only (control).
Clinical evaluation of the lesion through two components including objective morphological signs and subjective symptoms that describe the pain and burning sensation; will be measured at baseline and after 4 weeks of treatment
- Subjective findings (symptoms) using VAS score or burning sensation and pain ranging from 0 to 10 Changes in salivary INF-γ level (pg/mL) at baseline and after 4 weeks of treatment (measured using ELIZA technique)
- Treatment administration All participants will receive 40-60 mg of systemic prednisone as a single morning dose according to the severity. in the intervention group, a vitamin D supplement will be given as 60,000 IU weekly in conjunction with systemic steroids.
For the measurement of vitamin D3, The enzyme-linked immunosorbent assay (ELISA) will be used to process all samples simultaneously. Vitamin D levels lower than 30 ng/ml were assigned to vitamin D deficiency or insufficiency.
-Measurement of the inflammatory mediator (IFN-γ ) in saliva using (ELISA) kit After the initial diagnosis visit (during recruitment), patients will be clinically examined again for assessment of outcomes at baseline and after 1 month of treatment. Patients will be followed up for up to 60 days.
- Conditions
- Oral Lichen Planus, Vitamin D Deficiency
- Being tested
- vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone, Systemic prednisone
- Keywords
- vitamin D, Oral Lichen Planus, salivary IFN-γ
- Medical subject headings
- Lichen Planus, Oral, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisoneDrug
All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case. In addition, a vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.
Systemic prednisoneDrug
All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D+ Systemic steroids | Active comparator | vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids. Receives: Drug: vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone; Drug: Systemic prednisone |
| Systemic steroids alone | Active comparator | systemic steroids only Receives: Drug: Systemic prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of clinical presentation of the lesion
The severity of the clinical presentation of the lesion was calculated by multiplying (Sub-site score A) by (Severity score B) as Sub-site score A 0= no lesion
- evidence of lichen planus
- ≥50% of buccal mucosa, dorsum of the tongue, the floor of the mouth, hard palate, soft palate, or oropharynx affected Severity score B
0= keratosis only
- keratosis with mild erythema (≤ 3 mm from gingival margin)
- marked erythema (e.g. full thickness of gingivae, extensive with atrophy or edema on non-keratinized mucosa)
- ulceration present Severity of clinical appearance=A*B (sub-site score* severity score)
- Mild: 1-2
- Moderate: 3-4
- Severe: 5-6 Finally, the lesion was considered as persisting at follow-up if the clinical presentation score was greater than 0 where whereas a score of 0 indicated a healed lesion.
Measured: 1 months
Pain and burning sensation
VAS score or burning sensation and pain ranging from 0 to 10
- Mild : 0-4
- Moderate: 5-7
- Severe: 8-10
Measured: 1 months
Secondary outcomes (1)
Changes in salivary INF-γ level
Changes in salivary INF-γ level (pg/mL) at baseline and after 4 weeks of treatment (measured using ELIZA technique)
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Aug 2023
- 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.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Fayoum 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Shalby, Fayoum University
- Investigators
- Rania H Shalby, Principal investigator, Faculty of Dentistry-Fayoum UniversityYasmine G Hamid, phd, Principal investigator, Modern modern university for technology and information MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204796
- Sponsor's protocol ID
- 19038219038211013
- Status last verified
- Jan 2024
- First submitted
- 10 Sep 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06204796
- Acronym / sponsor ID
- 19038219038211013
- Conditions
- Oral Lichen Planus, Vitamin D Deficiency
- Keywords
- vitamin D, Oral Lichen Planus, salivary IFN-γ
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 12 Jan 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.
The goal of this clinical trial is to compare between the use of vitamin D supplement in conjunction with systemic steroids versus the use of systemic steroids alone in the management of patients with symptomatic Oral Lichen Planus lesions and the comparison of salivary Interferon gamma levels in both study groups before and after treatment
Detailed description
The objective of the research:
To investigate the role of vitamin D supplements in the management of vitamin D deficient oral lichen planus (OLP) patients and to examine its suppressive effect on pro-inflammatory cytokine (IFN-γ) in saliva samples of OLP patients
- Steps in short
1- Trial design: This study is a randomized clinical trial (RCT) having parallel groups with a 1:1 allocation ratio. This study will conform with the Consolidated Standards of Reporting Trials guidelines (CONSORT guidelines).
Middle-aged patients presenting with clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP (32) and having vitamin D deficiency or insufficiency (≤30 ng/ml) (33) will be included in the present study.
4-Intervention and study groups A total of 40 participants will be randomly and equally allocated into one of the two study groups to receive either, systemic steroids and vitamin D supplement (intervention) or systemic steroids only (control).
Clinical evaluation of the lesion through two components including objective morphological signs and subjective symptoms that describe the pain and burning sensation; will be measured at baseline and after 4 weeks of treatment
- Subjective findings (symptoms) using VAS score or burning sensation and pain ranging from 0 to 10 Changes in salivary INF-γ level (pg/mL) at baseline and after 4 weeks of treatment (measured using ELIZA technique)
- Treatment administration All participants will receive 40-60 mg of systemic prednisone as a single morning dose according to the severity. in the intervention group, a vitamin D supplement will be given as 60,000 IU weekly in conjunction with systemic steroids.
For the measurement of vitamin D3, The enzyme-linked immunosorbent assay (ELISA) will be used to process all samples simultaneously. Vitamin D levels lower than 30 ng/ml were assigned to vitamin D deficiency or insufficiency.
-Measurement of the inflammatory mediator (IFN-γ ) in saliva using (ELISA) kit After the initial diagnosis visit (during recruitment), patients will be clinically examined again for assessment of outcomes at baseline and after 1 month of treatment. Patients will be followed up for up to 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D+ Systemic steroids | Active comparator | Drug: vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone, Drug: Systemic prednisonevitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids. |
| Systemic steroids alone | Active comparator | Drug: Systemic prednisonesystemic steroids only |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Middle-aged patients
- Clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP
- Vitamin D deficiency or insufficiency (≤30 ng/ml)
Key exclusion criteria (5 listed)
- Oral mucosal lesion other than OLP
- Suspected restoration-related reaction
- Active periodontitis
- Patients receiving any topical or systemic medication that may affect SVDL or induce a lichenoid reaction
- Patient having systemic disease based on the detailed questionnaire of the modified Cornell Medical Index
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 |
|---|---|---|
| vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisoneAll participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case. In addition, a vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids. | Drug | Vitamin D+ Systemic steroids |
| Systemic prednisoneAll participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case. | Drug | Systemic steroids alone, Vitamin D+ Systemic steroids |
Primary outcome
Severity of clinical presentation of the lesion
Time frame: 1 months
The severity of the clinical presentation of the lesion was calculated by multiplying (Sub-site score A) by (Severity score B) as Sub-site score A 0= no lesion 1. evidence of lichen planus 2. ≥50% of buccal mucosa, dorsum of the tongue, the floor of the mouth, hard palate, soft palate, or oropharynx affected Severity score B 0= keratosis only 1. keratosis with mild erythema (≤ 3 mm from gingival margin) 2. marked erythema (e.g. full thickness of gingivae, extensive with atrophy or edema on non-keratinized mucosa) 3. ulceration present Severity of clinical appearance=A*B (sub-site score* severity score) * Mild: 1-2 * Moderate: 3-4 * Severe: 5-6 Finally, the lesion was considered as persisting at follow-up if the clinical presentation score was greater than 0 where whereas a score of 0 indicated a healed lesion.
Pain and burning sensation
Time frame: 1 months
VAS score or burning sensation and pain ranging from 0 to 10 * Mild : 0-4 * Moderate: 5-7 * Severe: 8-10
1 secondary outcome
Changes in salivary INF-γ level
Time frame: 1 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 12 Jan 2024.
- 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.
Rania H Shalby principal investigator
Faculty of Dentistry-Fayoum University
Yasmine G Hamid, phd principal investigator
Modern modern university for technology and information MTI University
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 vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone and Systemic prednisone in people with Oral Lichen Planus and Vitamin D Deficiency, run by Fayoum 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 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 12 Jan 2024. 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.
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?
Severity of clinical presentation of the lesion (time frame: 1 months). 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 12 Jan 2024.