Oral Lichen PlanusPhase 4NCT04193748
Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
A Phase 4 study testing Topical pomegranate seeds and peel extracts in people with Oral Lichen Planus, run by Cairo University at 2 sites in Egypt.
Trial summary
This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Topical pomegranate seeds and peel extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2019to 13 Dec 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent
Who cannot join
- Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Oral Medicine and Periodontology Department
Cairo
Faculty of Dentistry, Cairo University
Giza
About this study
This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus
Read the detailed description
Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).
- Conditions
- Oral Lichen Planus
- Being tested
- Topical pomegranate seeds and peel extracts
- Keywords
- pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.
- Medical subject headings
- Lichen Planus, Oral, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical pomegranate seeds and peel extractsDrug
Topical pomegranate seeds and peel extracts in the form of gel
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks. Receives: Drug: Topical pomegranate seeds and peel extracts |
| Group S | Experimental | Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks. Receives: Drug: Topical pomegranate seeds and peel extracts |
| Group P | Experimental | Topical pomegranate peel extract treatment has been repeated four times per day for four weeks. Receives: Drug: Topical pomegranate seeds and peel extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS)
Pain assessment scale
Measured: 4 weeks
Secondary outcomes (2)
Sign score
Score for clinical improvement of the signs
Measured: 4 weeks
OHIP-14 questionnaire
evaluate the oral health related quality of life
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Sep 2019
- Primary completion20 Nov 2019
- Study completion13 Dec 2019
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Zakaria Ibrahium Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193748
- Sponsor's protocol ID
- FacultyofDentistryCairoUni
- Status last verified
- Jan 2020
- First submitted
- 8 Dec 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the research not published yet.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04193748
- Acronym / sponsor ID
- FacultyofDentistryCairoUni
- Conditions
- Oral Lichen Planus
- Keywords
- pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 10 Dec 2019 (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.
This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus
Detailed description
Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Topical pomegranate seeds and peel extractsTopical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks. |
| Group S | Experimental | Drug: Topical pomegranate seeds and peel extractsTopical pomegranate seeds extract treatment has been repeated four times per day for four weeks. |
| Group P | Experimental | Drug: Topical pomegranate seeds and peel extractsTopical pomegranate peel extract treatment has been repeated four times per day for four weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent
Key exclusion criteria (1 listed)
- Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate
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 |
|---|---|---|
| Topical pomegranate seeds and peel extractsTopical pomegranate seeds and peel extracts in the form of gel | Drug | Control group, Group P, Group S |
Primary outcome
visual analog scale (VAS)
Time frame: 4 weeks
Pain assessment scale
2 secondary outcomes
Sign score
Time frame: 4 weeks
OHIP-14 questionnaire
Time frame: 4 weeks
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 5 Feb 2020.
- Individual participant dataSharing planned: No. Because the research not published yet.
Related trials for Oral Lichen Planus
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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
Degree of Adherence of Symptomatic OLP Patients to Their Medications
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Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical pomegranate seeds and peel extracts in people with Oral Lichen Planus, run by Cairo University at 2 sites 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 1 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
visual analog scale (VAS) (time frame: 4 weeks). 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 5 Feb 2020.