Oral Lichen PlanusPhase 3NCT06119672
Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment
A Phase 3 study testing Probiotic Blend Oral capsules and Corticosteroids for Local Oral Treatment in people with Oral Lichen Planus, run by October 6 University at 1 site in Egypt.
Trial summary
Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups -The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Probiotic Blend Oral capsules and Corticosteroids for Local Oral Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 30 Dec 2023
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus.
- Male or female patient with age range between 20-75 years old were included.
- medically free individuals
Who cannot join
- the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study.
- Pregnant females
- patients with history of systemic disorder affecting the immune system
- active liver diseases and cancer
- allergy or intolerance to probiotics.
- any other oral lesions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, +2
yasmine kamal, lecturer, 01002493331, dryasminekaml84@gmail.com
About this study
Official title: Evaluation of the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus
Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups
-The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks.
Read more
Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment .
Patient's visits was at baseline, 2 weeks and 4 weeks.
- Conditions
- Oral Lichen Planus
- Being tested
- Probiotic Blend Oral capsules, Corticosteroids for Local Oral Treatment
- Keywords
- oral lichen planus, probiotics, clobetasol probionate
- 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.
Probiotic Blend Oral capsulesDrug
probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily
Corticosteroids for Local Oral TreatmentDrug
Also called clobetasol probionate in orabase
topical clobetasol probionate in orabase application 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| systemic probiotic (A) | Active comparator | Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily Receives: Drug: Probiotic Blend Oral capsules; Drug: Corticosteroids for Local Oral Treatment |
| topical corticosteroid (B) | Active comparator | topical clobetasol in orabse application will be given 4 times daily ( 3 times after meals and once before bed time) prophylactic topical antifungal will be given in the fourth week to prevent candidal infection Receives: Drug: Corticosteroids for Local Oral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
size wound
thongprasom scale
Measured: 0 , 2 weeks and 4 weeks
Pain in oral cavity
Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain
Measured: 0 , 2 weeks and 4 weeks
Secondary outcomes (1)
candidal load assessment
culturing technique in CFU unit
Measured: 0 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 May 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Amira Abdelwhab, October 6 University
- Investigators
- yasmine kamal, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119672
- Sponsor's protocol ID
- 311122
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT06119672
- Acronym / sponsor ID
- 311122
- Conditions
- Oral Lichen Planus
- Keywords
- oral lichen planus, probiotics, clobetasol probionate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 7 Nov 2023 (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.
Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups
-The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks.
Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment .
Patient's visits was at baseline, 2 weeks and 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemic probiotic (A) | Active comparator | Drug: Probiotic Blend Oral capsules, Drug: Corticosteroids for Local Oral TreatmentSystemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily |
| topical corticosteroid (B) | Active comparator | Drug: Corticosteroids for Local Oral Treatmenttopical clobetasol in orabse application will be given 4 times daily ( 3 times after meals and once before bed time) prophylactic topical antifungal will be given in the fourth week to prevent candidal infection |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus.
- Male or female patient with age range between 20-75 years old were included.
- medically free individuals
Key exclusion criteria (6 listed)
- the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study.
- Pregnant females
- patients with history of systemic disorder affecting the immune system
- active liver diseases and cancer
- allergy or intolerance to probiotics.
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 |
|---|---|---|
| Probiotic Blend Oral capsulesprobtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily | Drug | systemic probiotic (A) |
| Corticosteroids for Local Oral TreatmentAlso: clobetasol probionate in orabasetopical clobetasol probionate in orabase application 4 times daily | Drug | systemic probiotic (A), topical corticosteroid (B) |
Primary outcome
size wound
Time frame: 0 , 2 weeks and 4 weeks
thongprasom scale
Pain in oral cavity
Time frame: 0 , 2 weeks and 4 weeks
Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain
1 secondary outcome
candidal load assessment
Time frame: 0 and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes
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Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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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.
yasmine kamal, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic Blend Oral capsules and Corticosteroids for Local Oral Treatment in people with Oral Lichen Planus, run by October 6 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 6 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: status not confirmed, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Abdelwhab, lecturer (01007647877, amira.abdelwhab.dent@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
size wound (time frame: 0 , 2 weeks and 4 weeks). 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 7 Nov 2023.