Oral Lichen PlanusPhase 3NCT02329600
Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus
A Phase 3 study testing green tea tablets (Green tea extract 5:1) 200 mg and Triamcinolone Acetonide in people with Oral Lichen Planus, run by Cairo University.
Trial summary
The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets. Read more about this study
- Who is it for?
- Ages 30 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- green tea tablets (Green tea extract 5:1) 200 mg and Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Oct 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presented with painful oral lichen planus lesions
- Free of any visible oral lesions other than oral lichen planus
- Free of any systemic diseases
Who cannot join
- Topical treatment or systemic therapy of OLP for one month before starting the study
- Pregnant or breast feeding women
- Smokers
- Use of corticosteroids or other immunosuppressive drugs
About this study
Official title: Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus
The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.
Read the detailed description
This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy control subjects not receiving medication.
Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
- Conditions
- Oral Lichen Planus
- Being tested
- green tea tablets (Green tea extract 5:1) 200 mg, Triamcinolone Acetonide
- 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.
green tea tablets (Green tea extract 5:1) 200 mgDrug
Also called Green Tea Polyphenolic Fraction
Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone AcetonideDrug
Also called Kenalog in orabase
topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
| Study group | Role | What they receive |
|---|---|---|
| control subjects | No intervention | 10 systemically healthy control subjects taking no medication. |
| OLP and corticosteroid | Active comparator | 15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month. Receives: Drug: Triamcinolone Acetonide |
| OLP and corticosteroid and green tea | Experimental | 15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month. Receives: Drug: green tea tablets (Green tea extract 5:1) 200 mg; Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment
Measured: one month after treatment
Secondary outcomes (1)
Salivary Total Oxidative Capacity
total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment
Measured: one month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJun 2013
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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 3
- 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
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Noha Ghallab, M.D., Study chair, Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.Enji Ahmed, M.D., Study director, Lecturer of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.Ghada Nabil, B.D.S, Principal investigator, Instructor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329600
- Sponsor's protocol ID
- polyphenol_TOC_OLP
- Status last verified
- Sep 2016
- First submitted
- 29 Dec 2014
- Last updated
- 15 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Agha-Hosseini F, Mirzaii-Dizgah I, Farmanbar N, Abdollahi M. Oxidative stress status and DNA damage in saliva of human subjects with oral lichen planus and oral squamous cell carcinoma. J Oral Pathol Med. 2012 Nov;41(10):736-40. doi: 10.1111/j.1600-0714.2012.01172.x. Epub 2012 May 15.
PubMed 22582895Nakagawa T, Yokozawa T. Direct scavenging of nitric oxide and superoxide by green tea. Food Chem Toxicol. 2002 Dec;40(12):1745-50. doi: 10.1016/s0278-6915(02)00169-2.
PubMed 12419687Sander CS, Cooper SM, Ali I, Dean D, Thiele JJ, Wojnarowska F. Decreased antioxidant enzyme expression and increased oxidative damage in erosive lichen planus of the vulva. BJOG. 2005 Nov;112(11):1572-5. doi: 10.1111/j.1471-0528.2005.00743.x.
PubMed 16225582Singh BN, Shankar S, Srivastava RK. Green tea catechin, epigallocatechin-3-gallate (EGCG): mechanisms, perspectives and clinical applications. Biochem Pharmacol. 2011 Dec 15;82(12):1807-21. doi: 10.1016/j.bcp.2011.07.093. Epub 2011 Jul 30.
PubMed 21827739Zhang J, Zhou G. Green tea consumption: an alternative approach to managing oral lichen planus. Inflamm Res. 2012 Jun;61(6):535-9. doi: 10.1007/s00011-012-0440-z. Epub 2012 Feb 10.
PubMed 22322481
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT02329600
- Acronym / sponsor ID
- polyphenol_TOC_OLP
- Conditions
- Oral Lichen Planus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Posted 15 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.
Detailed description
This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy control subjects not receiving medication.
Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control subjects | No intervention | –10 systemically healthy control subjects taking no medication. |
| OLP and corticosteroid | Active comparator | Drug: Triamcinolone Acetonide15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month. |
| OLP and corticosteroid and green tea | Experimental | Drug: green tea tablets (Green tea extract 5:1) 200 mg, Drug: Triamcinolone Acetonide15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month. |
Who may qualify
- Ages
- 30 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presented with painful oral lichen planus lesions
- Free of any visible oral lesions other than oral lichen planus
- Free of any systemic diseases
Key exclusion criteria (4 listed)
- Topical treatment or systemic therapy of OLP for one month before starting the study
- Pregnant or breast feeding women
- Smokers
- Use of corticosteroids or other immunosuppressive drugs
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 |
|---|---|---|
| green tea tablets (Green tea extract 5:1) 200 mgAlso: Green Tea Polyphenolic FractionGreen tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally. | Drug | OLP and corticosteroid and green tea |
| Triamcinolone AcetonideAlso: Kenalog in orabasetopical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month | Drug | OLP and corticosteroid, OLP and corticosteroid and green tea |
Primary outcome
Pain
Time frame: one month after treatment
pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment
1 secondary outcome
Salivary Total Oxidative Capacity
Time frame: one month after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22582895Agha-Hosseini F, Mirzaii-Dizgah I, Farmanbar N, Abdollahi M. Oxidative stress status and DNA damage in saliva of human subjects with oral lichen planus and oral squamous cell carcinoma. J Oral Pathol Med. 2012 Nov;41(10):736-40. doi: 10.1111/j.1600-0714.2012.01172.x. Epub 2012 May 15.
- Results publication: PubMed 12419687Nakagawa T, Yokozawa T. Direct scavenging of nitric oxide and superoxide by green tea. Food Chem Toxicol. 2002 Dec;40(12):1745-50. doi: 10.1016/s0278-6915(02)00169-2.
- Results publication: PubMed 16225582Sander CS, Cooper SM, Ali I, Dean D, Thiele JJ, Wojnarowska F. Decreased antioxidant enzyme expression and increased oxidative damage in erosive lichen planus of the vulva. BJOG. 2005 Nov;112(11):1572-5. doi: 10.1111/j.1471-0528.2005.00743.x.
- Results publication: PubMed 21827739Singh BN, Shankar S, Srivastava RK. Green tea catechin, epigallocatechin-3-gallate (EGCG): mechanisms, perspectives and clinical applications. Biochem Pharmacol. 2011 Dec 15;82(12):1807-21. doi: 10.1016/j.bcp.2011.07.093. Epub 2011 Jul 30.
- Results publication: PubMed 22322481Zhang J, Zhou G. Green tea consumption: an alternative approach to managing oral lichen planus. Inflamm Res. 2012 Jun;61(6):535-9. doi: 10.1007/s00011-012-0440-z. Epub 2012 Feb 10.
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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.
Noha Ghallab, M.D. study chair
Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Enji Ahmed, M.D. study director
Lecturer of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Ghada Nabil, B.D.S principal investigator
Instructor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing green tea tablets (Green tea extract 5:1) 200 mg and Triamcinolone Acetonide in people with Oral Lichen Planus, run by Cairo University.
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 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 15 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain (time frame: one month after treatment). 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 NCT02329600, which also lists 5 linked publications.
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 15 Nov 2016.