ClinicalTrials.gg
Not yet recruitingNCT05882864Updated May 31, 2023

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

A Phase 4 interventional study of 6-Gingerol and Triamcinolone Acetonide 0.1% Oromucosal Paste in Oral Lichen Planus, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Lichen Planus, Oral by Ain Shams University — 3 open to participants now, 4 under way, none of them phase 3. Lichen Planus, Oral · Ain Shams University.

Started
2023
the only one that year
Phase 4
7 of 10
1 open now
Registered
4th of 10
by date

Among the 10 studies in Lichen Planus, Oral by Ain Shams University, this one is the only one that started in 2023, is one of 7 in phase 4, and was the 4th registered.

Lichen Planus, Oral

142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.

Browse Lichen Planus, Oral studies →

Open to participants now

3 of the 10 studies in Lichen Planus, Oral by Ain Shams University are open now. Recruiting first, the newest first:

All 3 open studies →

Where they have run

Who these studies take

Of the 14 Lichen Planus, Oral studies recruiting now, 10 (71%) set no upper age limit and 2 (14%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.

This study: 40 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Lichen Planus, Oral by Ain Shams University, or all of them as a file.
02

Study 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 Objective).
03

Conditions studied

  • Oral Lichen Planus

Browse trials for

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • History of drug induced lichenoid lesions.
  • Presence of systemic conditions as; serious active or recurrent infections, , 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 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, or drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study (Swift et al., 2005).
  • 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).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
28 participants (estimated)

Study arms

  • Active comparator
    Topical 6-Gingerol Group

    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).

    Drug: 6-Gingerol

  • Active comparator
    Topical Steroid Group

    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.

    Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste

Interventions

  • Drug6-Gingerol

    6-gingerol gel will be applied locally to the participants suffering from oral lichen planus

  • Triamcinolone Acetonide 0.1% gel will be applied locally to the participants suffering from oral lichen planus

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
  • Grzanna R, Lindmark L, Frondoza CG. Ginger--an herbal medicinal product with broad anti-inflammatory actions. J Med Food. 2005 Summer;8(2):125-32. doi: 10.1089/jmf.2005.8.125. PubMed 16117603 ↗
  • Haghpanah P, Moghadamnia AA, Zarghami A, Motallebnejad M. Muco-bioadhesive containing ginger officinal e extract in the management of recurrent aphthous stomatitis: A randomized clinical study. Caspian J Intern Med. 2015 Winter;6(1):3-8. PubMed 26221489 ↗
  • Ismail SB, Kumar SK, Zain RB. Oral lichen planus and lichenoid reactions: etiopathogenesis, diagnosis, management and malignant transformation. J Oral Sci. 2007 Jun;49(2):89-106. doi: 10.2334/josnusd.49.89. PubMed 17634721 ↗
  • Jolad SD, Lantz RC, Solyom AM, Chen GJ, Bates RB, Timmermann BN. Fresh organically grown ginger (Zingiber officinale): composition and effects on LPS-induced PGE2 production. Phytochemistry. 2004 Jul;65(13):1937-54. doi: 10.1016/j.phytochem.2004.06.008. PubMed 15280001 ↗
  • Laeijendecker R, Tank B, Dekker SK, Neumann HA. A comparison of treatment of oral lichen planus with topical tacrolimus and triamcinolone acetonide ointment. Acta Derm Venereol. 2006;86(3):227-9. doi: 10.2340/00015555-0070. PubMed 16710580 ↗
  • Li C, Tang X, Zheng X, Ge S, Wen H, Lin X, Chen Z, Lu L. Global Prevalence and Incidence Estimates of Oral Lichen Planus: A Systematic Review and Meta-analysis. JAMA Dermatol. 2020 Feb 1;156(2):172-181. doi: 10.1001/jamadermatol.2019.3797. PubMed 31895418 ↗
  • Lopez-Jornet P, Camacho-Alonso F, Salazar-Sanchez N. Topical tacrolimus and pimecrolimus in the treatment of oral lichen planus: an update. J Oral Pathol Med. 2010 Mar;39(3):201-5. doi: 10.1111/j.1600-0714.2009.00830.x. Epub 2009 Nov 20. PubMed 19943858 ↗
  • Lozada-Nur F, Miranda C. Oral lichen planus: epidemiology, clinical characteristics, and associated diseases. Semin Cutan Med Surg. 1997 Dec;16(4):273-7. doi: 10.1016/s1085-5629(97)80016-8. PubMed 9421218 ↗
  • Mashhadi NS, Ghiasvand R, Askari G, Feizi A, Hariri M, Darvishi L, Barani A, Taghiyar M, Shiranian A, Hajishafiee M. Influence of ginger and cinnamon intake on inflammation and muscle soreness endued by exercise in Iranian female athletes. Int J Prev Med. 2013 Apr;4(Suppl 1):S11-5. PubMed 23717759 ↗
  • Mozaffari HR, Sharifi R, Sadeghi M. Prevalence of Oral Lichen Planus in Diabetes Mellitus: a Meta-Analysis Study. Acta Inform Med. 2016 Dec;24(6):390-393. doi: 10.5455/aim.2016.24.390-393. PubMed 28077900 ↗
  • Nagata S. Apoptosis regulated by a death factor and its receptor: Fas ligand and Fas. Philos Trans R Soc Lond B Biol Sci. 1994 Aug 30;345(1313):281-7. doi: 10.1098/rstb.1994.0107. PubMed 7531345 ↗
  • Nagata S. Fas ligand-induced apoptosis. Annu Rev Genet. 1999;33:29-55. doi: 10.1146/annurev.genet.33.1.29. PubMed 10690403 ↗
  • Pedersen A. Abnormal EBV immune status in oral lichen planus. Oral Dis. 1996 Jun;2(2):125-8. doi: 10.1111/j.1601-0825.1996.tb00212.x. PubMed 8957924 ↗
  • Pendleton N, Clague JE, Horan MA, Rabbitt PM, Jones M, Coward R, Lowe C, McInnes L. Concordance of Cornell medical index self-reports to structured clinical assessment for the identification of physical health status. Arch Gerontol Geriatr. 2004 May-Jun;38(3):261-9. doi: 10.1016/j.archger.2003.10.005. PubMed 15066312 ↗
  • Peter ME, Krammer PH. Mechanisms of CD95 (APO-1/Fas)-mediated apoptosis. Curr Opin Immunol. 1998 Oct;10(5):545-51. doi: 10.1016/s0952-7915(98)80222-7. PubMed 9794832 ↗
  • Prasad S, Tyagi AK. Ginger and its constituents: role in prevention and treatment of gastrointestinal cancer. Gastroenterol Res Pract. 2015;2015:142979. doi: 10.1155/2015/142979. Epub 2015 Mar 8. PubMed 25838819 ↗
  • Radwan-Oczko M, Zwyrtek E, Owczarek JE, Szczesniak D. Psychopathological profile and quality of life of patients with oral lichen planus. J Appl Oral Sci. 2018 Jan 18;26:e20170146. doi: 10.1590/1678-7757-2017-0146. PubMed 29364344 ↗
  • Ramalingam S, Malathi N, Thamizhchelvan H, Sangeetha N, Rajan ST. Role of Mast Cells in Oral Lichen Planus and Oral Lichenoid Reactions. Autoimmune Dis. 2018 Jan 17;2018:7936564. doi: 10.1155/2018/7936564. eCollection 2018. PubMed 29593898 ↗
  • Regezi JA, Dekker NP, MacPhail LA, Lozada-Nur F, McCalmont TH. Vascular adhesion molecules in oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Jun;81(6):682-90. doi: 10.1016/s1079-2104(96)80074-6. PubMed 8784900 ↗
  • Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available. PubMed 1026900 ↗
  • Kongiel-Chablo I. [Behavior of complex cyanides in natural water with high rate of contamination]. Rocz Panstw Zakl Hig. 1966;17(1):95-102. No abstract available. Polish. PubMed 5942912 ↗
  • Swift JC, Rees TD, Plemons JM, Hallmon WW, Wright JC. The effectiveness of 1% pimecrolimus cream in the treatment of oral erosive lichen planus. J Periodontol. 2005 Apr;76(4):627-35. doi: 10.1902/jop.2005.76.4.627. PubMed 15857105 ↗
  • Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. doi: 10.1111/j.1600-0714.1992.tb00974.x. PubMed 1460584 ↗
  • Tripathi S, Bruch D, Kittur DS. Ginger extract inhibits LPS induced macrophage activation and function. BMC Complement Altern Med. 2008 Jan 3;8:1. doi: 10.1186/1472-6882-8-1. PubMed 18173849 ↗
  • Tripathi P, Tripathi P, Kashyap L, Singh V. The role of nitric oxide in inflammatory reactions. FEMS Immunol Med Microbiol. 2007 Dec;51(3):443-52. doi: 10.1111/j.1574-695X.2007.00329.x. Epub 2007 Sep 27. PubMed 17903207 ↗
  • van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x. PubMed 12969224 ↗
  • Xue JL, Fan MW, Wang SZ, Chen XM, Li Y, Wang L. A clinical study of 674 patients with oral lichen planus in China. J Oral Pathol Med. 2005 Sep;34(8):467-72. doi: 10.1111/j.1600-0714.2005.00341.x. PubMed 16091113 ↗
  • Yildirim B, Senguven B, Demir C. Prevalence of herpes simplex, Epstein Barr and human papilloma viruses in oral lichen planus. Med Oral Patol Oral Cir Bucal. 2011 Mar 1;16(2):e170-4. doi: 10.4317/medoral.16.e170. PubMed 21196875 ↗
  • Zakrzewska JM, Chan ES, Thornhill MH. A systematic review of placebo-controlled randomized clinical trials of treatments used in oral lichen planus. Br J Dermatol. 2005 Aug;153(2):336-41. doi: 10.1111/j.1365-2133.2005.06493.x. PubMed 16086745 ↗
  • de Wied D. [Neuropeptides and behavior. The neuropeptide concept]. Ned Tijdschr Geneeskd. 1979 Sep 15;123(37):1589-90. No abstract available. Dutch. PubMed 39262 ↗
  • Van Zee KJ, Coyle SM, Calvano SE, Oldenburg HS, Stiles DM, Pribble J, Catalano M, Moldawer LL, Lowry SF. Influence of IL-1 receptor blockade on the human response to endotoxemia. J Immunol. 1995 Feb 1;154(3):1499-507. PubMed 7822813 ↗
  • Scully C, el-Kom M. Lichen planus: review and update on pathogenesis. J Oral Pathol. 1985 Jul;14(6):431-58. doi: 10.1111/j.1600-0714.1985.tb00516.x. PubMed 3926971 ↗
  • Sugerman PB, Savage NW, Walsh LJ, Zhao ZZ, Zhou XJ, Khan A, Seymour GJ, Bigby M. The pathogenesis of oral lichen planus. Crit Rev Oral Biol Med. 2002;13(4):350-65. doi: 10.1177/154411130201300405. PubMed 12191961 ↗
  • Thongprasom K, Dhanuthai K. Steriods in the treatment of lichen planus: a review. J Oral Sci. 2008 Dec;50(4):377-85. doi: 10.2334/josnusd.50.377. PubMed 19106464 ↗
  • Kramer IR, Lucas RB, Pindborg JJ, Sobin LH. Definition of leukoplakia and related lesions: an aid to studies on oral precancer. Oral Surg Oral Med Oral Pathol. 1978 Oct;46(4):518-39. No abstract available. PubMed 280847 ↗
  • Atterhog JH, Duner H, Pernow B. Experience with pindolol, a betareceptor blocker, in the treatment of hypertension. Am J Med. 1976 May 31;60(6):872-6. doi: 10.1016/0002-9343(76)90907-4. PubMed 14501 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2023; primary completion for Jun 2025, 22 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2023
First posted
May 31, 2023
StartEst.
Aug 1, 2023
Primary completionEst.
Jun 1, 2025
CompletionEst.
Aug 1, 2025
Last update
May 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05882864
Responsible party
Sponsor
First posted
May 31, 2023
Start date
Aug 1, 2023 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
May 31, 2023

Study contacts

Marwa Shehata, Bachelor
Contact
marwa_dnt@hotmail.com
+201007493498
Ola Ezzat, Ass. Pro.
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Triamcinolone Acetonide

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