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NCT05882864

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

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-08-01

Brief Summary

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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).

Detailed Description

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Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The study is designed to be a prospective randomized double blind 2 parallel arms controlled clinical trial.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

6-Gingerol

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide 0.1% Oromucosal Paste

Intervention Type DRUG

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

Interventions

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6-Gingerol

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

Intervention Type DRUG

Triamcinolone Acetonide 0.1% Oromucosal Paste

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

Intervention Type DRUG

Eligibility Criteria

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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

* 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).
* 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).

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Marwa Shehata, Bachelor

Role: CONTACT

Phone: +201007493498

Email: [email protected]

Ola Ezzat, Ass. Pro.

Role: CONTACT

References

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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.

Reference Type BACKGROUND

PMID: 19277504 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17950516 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 31860983 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 21152791 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11480643 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16785369 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18093246 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9916983 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11078140 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 6020677 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9421220 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 20082959 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17695343 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32144836 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 24672362 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16117603 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 26221489 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17634721 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15280001 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16710580 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 31895418 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19943858 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9421218 (View on PubMed)

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.

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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.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Herbs in oral medicine

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Topical 6-Gingerol Group

6-Gingerol

Topical Steroid Group

Triamcinolone Acetonide 0.1% Oromucosal Paste

Interventions

6-Gingerol

Triamcinolone Acetonide 0.1% Oromucosal Paste

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ain Shams University

Responsible Party

Central Contacts

Marwa Shehata, Bachelor

Ola Ezzat, Ass. Pro.

References

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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Herbs in oral medicine