Oral Lichen PlanusPhase 4NCT05882864

Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus With Immunohistochemical Analysis

A Phase 4 study testing 6-Gingerol and Triamcinolone Acetonide 0.1% Oromucosal Paste in people with Oral Lichen Planus, run by Ain Shams University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

1. Compare the clinical efficacy of topical ginger extract versus triamcinolone acetonide 0.1% for symptomatic oral lichen planus (Primary Objective). 2. Investigate using immunohistochemical analysis the effect of the two different treatment modalities on FasL expression in oral lichen planus lesions (Secondary… Read more about this study

Who is it for?: Ages 40 to 60 years
Conditions the study is for: Oral Lichen Planus
What is being tested?: 6-Gingerol and Triamcinolone Acetonide 0.1% Oromucosal Paste
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: No sites listed yet
Study dates: 1 Aug 2023to 1 Aug 2025
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 40 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Males or females, aged from 40 to 60 years.
Clinically proven painful Bullous/erosive (score 4) or atrophic (score 3) forms of OLP confirmed by the presence of red or erythromatous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae) (Lozada-Nur and Miranda, 1997)
Histopathologically, proven Bullous/erosive (score 4) or atrophic (score 3) forms of OLP confirmed by the presence of accepted histopathological criteria for lichen planus; basal cell liquefaction, band like lymphocytic infiltrate at the epithelial-stromal junction with degeneration of basal cell region (Ellis, 1967; Van der Meij and Van der Waal, 2003).

Who cannot join

History of drug induced lichenoid lesions.
Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using medical questionnaire guided by Cornell Medical Index (Pendleton et al., 2004).
Smoking.
Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in medical history.
Pregnancy or breast-feeding.
History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study (Swift et al., 2005).

Show all 11Show fewer

Patients suffering from lichen planus skin lesions.
Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied.
Refusing to participate in the study.
Vulnerable groups (handicapped, orphans and prisoners).

Trial locations and contacts

No sites are listed yet.

Marwa Shehata, Bachelor contact

+201007493498

marwa_dnt@hotmail.com

Ola Ezzat, Ass. Pro. contact

About this study

Official title: Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis

Compare the clinical efficacy of topical ginger extract versus triamcinolone acetonide 0.1% for symptomatic oral lichen planus (Primary Objective).
Investigate using immunohistochemical analysis the effect of the two different treatment modalities on FasL expression in oral lichen planus lesions (Secondary Objective).

Conditions: Oral Lichen Planus
Being tested: 6-Gingerol, Triamcinolone Acetonide 0.1% Oromucosal Paste
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.

6-GingerolDrug
6-gingerol gel will be applied locally to the participants suffering from oral lichen planus
Triamcinolone Acetonide 0.1% Oromucosal PasteDrug
Triamcinolone Acetonide 0.1% gel will be applied locally to the participants suffering from oral lichen planus

Study groups in NCT05882864
Study group	Role	What they receive
Topical 6-Gingerol Group	Active comparator	Group I Will include 14 patients receiving topical ginger extract 1% four times per day (after every meal and before going to bed) for eight weeks (Zakaria et al., 2020). Receives: Drug: 6-Gingerol
Topical Steroid Group	Active comparator	Group II Will include 14 patients receiving topical steroid (triamcinolone acetonide 0.1%) four times per day for eight weeks (Laeijendecker et al., 2006) In the fourth and eighth weeks, topical anti-fungal will be applied by a third-party medical personnel to avoid 2ry candidiasis for this group. Receives: Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus
Analysis of 6-Gingerol gel in Management of Oral Lichen Plauns using Immunohistochemistry
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20231 Aug 2025

First posted31 May 2023
Study start1 Aug 2023 (estimated)
Primary completion1 Jun 2025 (estimated)
Study completion1 Aug 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (51)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 Ain Shams 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
Model description: Group I Will include 14 patients receiving topical ginger extract 1% four times per day (after every meal and before going to bed) for eight weeks (Zakaria et al., 2020). Group II Will include 14 patients receiving topical steroid (triamcinolone acetonide 0.1%) four times per day for eight weeks (Laeijendecker et al., 2006)
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05882864
Sponsor's protocol ID: Herbs in oral medicine
Status last verified: May 2023
First submitted: 22 May 2023
Last updated: 31 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ahn SI, Lee JK, Youn HS. Inhibition of homodimerization of toll-like receptor 4 by 6-shogaol. Mol Cells. 2009 Feb 28;27(2):211-5. doi: 10.1007/s10059-009-0026-y. Epub 2009 Feb 20.
PubMed 19277504
Ali BH, Blunden G, Tanira MO, Nemmar A. Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): a review of recent research. Food Chem Toxicol. 2008 Feb;46(2):409-20. doi: 10.1016/j.fct.2007.09.085. Epub 2007 Sep 18.
PubMed 17950516
Anitua E, Pinas L, Alkhraisat MH. Histopathological features of oral lichen planus and its response to corticosteroid therapy: A retrospective study. Medicine (Baltimore). 2019 Dec;98(51):e18321. doi: 10.1097/MD.0000000000018321.
PubMed 31860983
Canto AM, Muller H, Freitas RR, Santos PS. Oral lichen planus (OLP): clinical and complementary diagnosis. An Bras Dermatol. 2010 Sep-Oct;85(5):669-75. doi: 10.1590/s0365-05962010000500010.
PubMed 21152791
Chainani-Wu N, Silverman S Jr, Lozada-Nur F, Mayer P, Watson JJ. Oral lichen planus: patient profile, disease progression and treatment responses. J Am Dent Assoc. 2001 Jul;132(7):901-9. doi: 10.14219/jada.archive.2001.0302.
PubMed 11480643
Cheng A, Mann C. Oral erosive lichen planus treated with efalizumab. Arch Dermatol. 2006 Jun;142(6):680-2. doi: 10.1001/archderm.142.6.680. No abstract available.
PubMed 16785369
Choonhakarn C, Busaracome P, Sripanidkulchai B, Sarakarn P. The efficacy of aloe vera gel in the treatment of oral lichen planus: a randomized controlled trial. Br J Dermatol. 2008 Mar;158(3):573-7. doi: 10.1111/j.1365-2133.2007.08370.x. Epub 2007 Dec 17.
PubMed 18093246
Dragovich T, Rudin CM, Thompson CB. Signal transduction pathways that regulate cell survival and cell death. Oncogene. 1998 Dec 24;17(25):3207-13. doi: 10.1038/sj.onc.1202587.
PubMed 9916983
Eisenberg E. Oral lichen planus: a benign lesion. J Oral Maxillofac Surg. 2000 Nov;58(11):1278-85. doi: 10.1053/joms.2000.16629. No abstract available.
PubMed 11078140
Ellis FA. Histopathology of lichen planus based on analysis of one hundred biopsy specimens. J Invest Dermatol. 1967 Feb;48(2):143-8. doi: 10.1038/jid.1967.23. No abstract available.
PubMed 6020677
Eversole LR. Immunopathogenesis of oral lichen planus and recurrent aphthous stomatitis. Semin Cutan Med Surg. 1997 Dec;16(4):284-94. doi: 10.1016/s1085-5629(97)80018-1.
PubMed 9421220
Farhi D, Dupin N. Pathophysiology, etiologic factors, and clinical management of oral lichen planus, part I: facts and controversies. Clin Dermatol. 2010 Jan-Feb;28(1):100-8. doi: 10.1016/j.clindermatol.2009.03.004.
PubMed 20082959
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Gonzalez-Moles MA, Warnakulasuriya S, Gonzalez-Ruiz I, Gonzalez-Ruiz L, Ayen A, Lenouvel D, Ruiz-Avila I, Ramos-Garcia P. Worldwide prevalence of oral lichen planus: A systematic review and meta-analysis. Oral Dis. 2021 May;27(4):813-828. doi: 10.1111/odi.13323. Epub 2020 Apr 2.
PubMed 32144836
Gorouhi F, Davari P, Fazel N. Cutaneous and mucosal lichen planus: a comprehensive review of clinical subtypes, risk factors, diagnosis, and prognosis. ScientificWorldJournal. 2014 Jan 30;2014:742826. doi: 10.1155/2014/742826. eCollection 2014.
PubMed 24672362

Want to know more?

Marwa Shehata, Bachelor

+201007493498

marwa_dnt@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
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
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia

All Oral Lichen Planus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis
ClinicalTrials.gov ID: NCT05882864
Acronym / sponsor ID: Herbs in oral medicine
Conditions: Oral Lichen Planus
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 28 participants (estimated)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 1 Aug 2023 (estimated)
Primary completion: 1 Jun 2025 (estimated)
Study completion: 1 Aug 2025 (estimated)
First posted: 31 May 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.

Compare the clinical efficacy of topical ginger extract versus triamcinolone acetonide 0.1% for symptomatic oral lichen planus (Primary Objective).
Investigate using immunohistochemical analysis the effect of the two different treatment modalities on FasL expression in oral lichen planus lesions (Secondary Objective).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: Group I Will include 14 patients receiving topical ginger extract 1% four times per day (after every meal and before going to bed) for eight weeks (Zakaria et al., 2020). Group II Will include 14 patients receiving topical steroid (triamcinolone acetonide 0.1%) four times per day for eight weeks (Laeijendecker et al., 2006)

Arm	Type	Receives
Topical 6-Gingerol Group	Active comparator	Drug: 6-GingerolGroup I Will include 14 patients receiving topical ginger extract 1% four times per day (after every meal and before going to bed) for eight weeks (Zakaria et al., 2020).
Topical Steroid Group	Active comparator	Drug: Triamcinolone Acetonide 0.1% Oromucosal PasteGroup II Will include 14 patients receiving topical steroid (triamcinolone acetonide 0.1%) four times per day for eight weeks (Laeijendecker et al., 2006) In the fourth and eighth weeks, topical anti-fungal will be applied by a third-party medical personnel to avoid 2ry candidiasis for this group.

Who may qualify

Ages: 40 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Males or females, aged from 40 to 60 years.
Clinically proven painful Bullous/erosive (score 4) or atrophic (score 3) forms of OLP confirmed by the presence of red or erythromatous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae) (Lozada-Nur and Miranda, 1997)
Histopathologically, proven Bullous/erosive (score 4) or atrophic (score 3) forms of OLP confirmed by the presence of accepted histopathological criteria for lichen planus; basal cell liquefaction, band like lymphocytic infiltrate at the epithelial-stromal junction with degeneration of basal cell region (Ellis, 1967; Van der Meij and Van der Waal, 2003).

Key exclusion criteria (11 listed)

History of drug induced lichenoid lesions.
Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using medical questionnaire guided by Cornell Medical Index (Pendleton et al., 2004).
Smoking.
Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in medical history.
Pregnancy or breast-feeding.

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
6-Gingerol6-gingerol gel will be applied locally to the participants suffering from oral lichen planus	Drug	Topical 6-Gingerol Group
Triamcinolone Acetonide 0.1% Oromucosal PasteTriamcinolone Acetonide 0.1% gel will be applied locally to the participants suffering from oral lichen planus	Drug	Topical Steroid Group

Primary outcome

Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus
Time frame: Baseline
Analysis of 6-Gingerol gel in Management of Oral Lichen Plauns using Immunohistochemistry

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Background: PubMed 19277504Ahn SI, Lee JK, Youn HS. Inhibition of homodimerization of toll-like receptor 4 by 6-shogaol. Mol Cells. 2009 Feb 28;27(2):211-5. doi: 10.1007/s10059-009-0026-y. Epub 2009 Feb 20.
Background: PubMed 17950516Ali BH, Blunden G, Tanira MO, Nemmar A. Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): a review of recent research. Food Chem Toxicol. 2008 Feb;46(2):409-20. doi: 10.1016/j.fct.2007.09.085. Epub 2007 Sep 18.
Background: PubMed 31860983Anitua E, Pinas L, Alkhraisat MH. Histopathological features of oral lichen planus and its response to corticosteroid therapy: A retrospective study. Medicine (Baltimore). 2019 Dec;98(51):e18321. doi: 10.1097/MD.0000000000018321.
Background: PubMed 21152791Canto AM, Muller H, Freitas RR, Santos PS. Oral lichen planus (OLP): clinical and complementary diagnosis. An Bras Dermatol. 2010 Sep-Oct;85(5):669-75. doi: 10.1590/s0365-05962010000500010.
Background: PubMed 11480643Chainani-Wu N, Silverman S Jr, Lozada-Nur F, Mayer P, Watson JJ. Oral lichen planus: patient profile, disease progression and treatment responses. J Am Dent Assoc. 2001 Jul;132(7):901-9. doi: 10.14219/jada.archive.2001.0302.
Background: PubMed 16785369Cheng A, Mann C. Oral erosive lichen planus treated with efalizumab. Arch Dermatol. 2006 Jun;142(6):680-2. doi: 10.1001/archderm.142.6.680. No abstract available.
Background: PubMed 18093246Choonhakarn C, Busaracome P, Sripanidkulchai B, Sarakarn P. The efficacy of aloe vera gel in the treatment of oral lichen planus: a randomized controlled trial. Br J Dermatol. 2008 Mar;158(3):573-7. doi: 10.1111/j.1365-2133.2007.08370.x. Epub 2007 Dec 17.
Background: PubMed 9916983Dragovich T, Rudin CM, Thompson CB. Signal transduction pathways that regulate cell survival and cell death. Oncogene. 1998 Dec 24;17(25):3207-13. doi: 10.1038/sj.onc.1202587.
Background: PubMed 11078140Eisenberg E. Oral lichen planus: a benign lesion. J Oral Maxillofac Surg. 2000 Nov;58(11):1278-85. doi: 10.1053/joms.2000.16629. No abstract available.
Background: PubMed 6020677Ellis FA. Histopathology of lichen planus based on analysis of one hundred biopsy specimens. J Invest Dermatol. 1967 Feb;48(2):143-8. doi: 10.1038/jid.1967.23. No abstract available.
Background: PubMed 9421220Eversole LR. Immunopathogenesis of oral lichen planus and recurrent aphthous stomatitis. Semin Cutan Med Surg. 1997 Dec;16(4):284-94. doi: 10.1016/s1085-5629(97)80018-1.
Background: PubMed 20082959Farhi D, Dupin N. Pathophysiology, etiologic factors, and clinical management of oral lichen planus, part I: facts and controversies. Clin Dermatol. 2010 Jan-Feb;28(1):100-8. doi: 10.1016/j.clindermatol.2009.03.004.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Related trials for Oral Lichen Planus

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
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
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia

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.

Marwa Shehata, Bachelor contact

+201007493498

marwa_dnt@hotmail.com

Ola Ezzat, Ass. Pro. contact

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 6-Gingerol and Triamcinolone Acetonide 0.1% Oromucosal Paste in people with Oral Lichen Planus, run by Ain Shams 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 11 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 31 May 2023. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marwa Shehata, Bachelor (+201007493498, marwa_dnt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus (time frame: Baseline). 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 NCT05882864, which also lists 51 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 31 May 2023.