The Efficacy of Oral IMODTM in Oral Lichen Planus treatment;

a Randomized, Double-Blind Placebo-Controlled Trial


A vast variety of local and systemic treatments have been utilized in the management of oral lichen planus (OLP). The efficiency of IMOD (an Iranian new immunomodulatory drug, containing selenium, carotene, and flavonoids) in the treatment of OLP was assessed. In a randomized double-blind placebo/controlled trial study, 40 individuals (who referred to the oral and maxillofacial department of the School of Dentistry) with lichen planus were registered. The study enclosed a three-month period of therapy by IMOD (480 mg/day) (n=20) or placebo (n=20), and a three-month follow-up period after drug interruption. Consequence measures contain pain or burning severity, clinical score, clinical global impression of change (CGIC) and patient global impression of change (PGIC). Unstimulated saliva levels of total antioxidant capacity (TAC), Malondialdehyde (MDA), uric acid and TNF-α were tested at the baseline and after treatment and calculated their changes. Statistical analysis of Mann-Whitney and unpaired student’s t-test were used. There were no noteworthy changes between placebo and IMOD treaded groups in pain or burning severity, clinical score, CGIC and PGIC following 2,4,8,12, and 24 weeks following treatment and also in saliva TAC, MDA, TNF-α and uric acid changes. IMOD lacks proper efficacy in the management of severe or very severe OLP lesions. 

[1] Devi M, Vijayalakshmi D, Dhivya K, Janane M. Memory T Cells (CD45RO) Role and Evaluation in Pathogenesis of Lichen Planus and Lichenoid Mucositis. J Clin Diagn Res. 2017; 11(5): ZC84-ZC86
[2] Agha-Hosseini F, Khalili M, Rohani B. Immunohistochemistry Analysis of P53 and Ki-67 Proteins in Oral Lichen Planus and Normal Oral Mucosa. Iran J Public Health. 2009; 38(2):37-43.
[3] Agha-Hosseini F, Barati H, Moosavi MS. Aquaporin3 (AQP3) expression in oral epithelium in oral lichen planus. Exp Mol Pathol. 2020; 115:104441. doi: 10.1016/j.yexmp.2020.104441.
[4] Bakhtiari S, Mojahedi SM, Azari-Marhabi S, Namdari M, Rankohi ZE. Comparing clinical effects of photodynamic therapy as a novel method with topical corticosteroid for treatment of Oral Lichen Planus. Photodiagnosis Photodyn Ther. 2017; pii: S1572-1000(16)30110-7.
[5] Khairandish P, Mohraz M, Farzamfar B, Abdollahi M, Shahhosseiny MH, Madani H, Sadeghi B, Heshmat R, Gharibdoust F, Khorram-Khorshid HR. Preclinical and phase 1 clinical safety of Setarud (IMOD™), a novel immunomodulator. DARU Journal of Pharmaceutical Sciences 2009. 17(3):148-156.
[6] Kato AM, Hegab DS, Sweilam MA, Abd El Gaffar ES. Serum levels of tumor necrosis factor-α in patients with lichen planus. Egypt J Dermatol Venerol 2014; 34:102-6.
[7] Mishra SS, Uma Maheswari TN. Evaluation of oxidative stress in oral lichen planus using malonaldehyde: A systematic review. J Dermatol Dermatol Surg 2014; 18 (1): 2–7.
[8] Agha-Hosseini F, Mirzaii-Dizgah I, Miri-Zarandi N. Unstimulated salivary p53 in patients with oral lichen planus and squamous cell carcinoma. Acta Med Iran. 2015; 53(7):439-43.
[9] Miricescu D, Greabu M, Totan A, Didilescu A, Rădulescu R. The antioxidant potential of saliva: clinical significance in oral diseases. Ther Pharmacol Clin Toxicol 2011; 15(2):139–43.
[10] Shirzad A, Pouramir M, Seyedmajidi M, Jenabian N, Bijani A, Motallebnejad M. Salivary total antioxidant capacity and lipid peroxidation in patients with erosive oral lichen planus. J Dent Res Dent Clin Dent Prospects 2014; 8(1):35-9. doi: 10.5681/joddd.2014.006.
[11] Shiva A, Arab S. Evaluation of Uric Acid, Total Antioxidant and Lipid Peroxidation Parameters in Serum and Saliva of Patients with Oral Lichen Planus. Glob J Health Sci 2016; 8(12):58037.
[12] Chakraborti G, Biswas R, Chakraborti S, Sen PK. Altered serum uric Acid level in lichen planus patients. Indian J Dermatol 2014; 59(6):558-61.
[13] Agha-Hosseini F, Mirzaii-Dizgah I, Mohammadpour N. Muscarinic cholinergic receptors (MR3) in saliva of patients with oral lichen planus. Arch Dermatol Res. 2016; 308(7):481-6.
[14] Agha-Hosseini F; Mirzaii-Dizgah I, Mohebbian M; Sarookani MR. Vascular endothelial growth factor in serum and saliva of oral lichen planus and oral squamous cell carcinoma patients. Journal of Kerman University of Medical Sciences, 2018; 25 (1): 27-33
[15] Mahboobi N, Agha-Hosseini F, Lankarani KB. Hepatitis C virus and lichen planus: the real association. Hepat Mon. 2010; 10(3):161-4.
[16] Agha-Hosseini F, Imanpour M, Mirzaii-Dizgah I, Moosavi MS. Mucin 5B in saliva and serum of patients with oral lichen planus. Sci Rep. 2017; 7(1):12060. doi: 10.1038/s41598-017-12157-1.
[17] Agha-Hosseini F, Mirzaii-Dizgah I, Mirjalili N. Relationship of unstimulated saliva cortisol level with severity of oral dryness feeling in menopausal women. Aust Dent J. 2011 Jun;56(2):171-4. doi: 10.1111/j.1834-7819.2011.01320. x.
[18] Agha-Hosseini F, Mirzaii-Dizgah I, Mirjalili N. Relationship of stimulated whole saliva cortisol level with the severity of a feeling of dry mouth in menopausal women. Gerodontology. 2012 Mar;29(1):43-7. doi: 10.1111/j.1741-2358.2010. 00403.x
[19] Agha-Hosseini F, Mirzaii-Dizgah I, Abdollahi M, Akbari-Gillani N. Efficacy of IMOD in the treatment of oral lichen planus. Open J Stomatol 2011; 1:13-17.
[20] Erel O. A novel automated direct measurement method for total antioxidant capacity using a new generation, more stable ABTS radical cation. Clin Biochem. 2004; 37(4):277–85.
[21] Kurago ZB. Etiology and pathogenesis of oral lichen planus: an overview. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016; 122:72-80.
[22] Xia J, Li C, Hong Y, Yang L, Huang Y, Cheng B. Short-term clinical evaluation of intralesional triamcinolone acetonide injection for ulcerative oral lichen planus. J Oral Pathol Med 2006; 35(6):327-31.
[23] Payeras MR, Cherubini K, Figueiredo MA, Salum FG. Oral lichen planus: focus on etiopathogenesis. Arch Oral Biol. 2013; 58(9):1057-69.
[24] Farhi D, Dupin N. Pathophysiology, etiologic factors, and clinical management of oral lichen planus, part I: facts and controversies. Clin Dermatol 2010; 28(1):100-8. doi: 10.1016/j.clindermatol.2009.03.004.
[25] Lavanya N, Jayanthi P, Rao UK, Ranganathan K. Oral lichen planus: An update on pathogenesis and treatment. J Oral Maxillofac Pathol 2011; 15(2):127-32.
[26] Agrawal B, Shrivastav S, Singhal B. Management of oral lichen planus-A review. Cent India J Dent Sci 2012;3(1):54-60
IssueVol 6, No 1 (Winter 2020) QRcode
Oral Lichen Planus; IMOD; TNF-α; TAC; MDA

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
Agha-Hosseini F, Najafi S, Mirzaii-Dizgah I, Ostovar A. The Efficacy of Oral IMODTM in Oral Lichen Planus treatment;. J Nutr Sci & Diet. 2022;6(1):1-7.