The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients

Overview

Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus. – Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva. – Compare the outcome of new preparation with the gold standard treatment (corticosteroids).

Full Title of Study: “The Effect of Topical Curcumin Versus Topical Corticosteroid on Pain, Clinical Parameters and Salivary Level of IL-33 in Oral Lichen Planus Patients: A Randomized Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 1, 2020

Detailed Description

Two groups will be prepared then decision of which one take curcumin paste will be selected according to randomized numbers in a sequentially numbered, opaque, sealed envelope 1 group will take topical corticosteroid and 1 will take curcumin paste then IL-33 level in saliva will be measured at the base line and at the end of 4th week pain and clinical parameters will be measured at 2nd and 4th week

Interventions

  • Drug: Triamcinolone
    • Triamcenolone +napolycarboxylate
  • Drug: Turmeric paste
    • Topical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University

Arms, Groups and Cohorts

  • Experimental: turmeric paste
    • Topical curcumin gel (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University traumeric extracted from Curcuma plant, it has anti-inflammatory, antioxidative and antineoplastic properties ((Nosratzehi et al., 2018), The curcumin is safe even in high doses, Since oxidative stress may play a role in pathophysiology of OLP, and by noting that OLP is a chronic inflammatory disease, the herbs which have both anti-inflammatory and antioxidant properties may efficiently control OLP (Kia et al., 2015).
  • Active Comparator: Triamcenolone in orabase
    • Triamcenolone + na ploycarboxylate

Clinical Trial Outcome Measures

Primary Measures

  • Pain intensity
    • Time Frame: 4 weeks
    • measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain

Secondary Measures

  • clinical sign score
    • Time Frame: Baseline , 2nd week and 4th week
    • measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm
  • IL-33 level in saliva
    • Time Frame: base line and 4th week
    • by ELISA

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who will be clinically diagnosed as having atrophic &/or erosive oral lichen planus. – Patients with controlled diabetes and/or controlled hypertension will be included in the study. – Patients with no history of taking corticosteroids for the last 6 months – Patients who agrees to take medication. Exclusion Criteria:

  • Pregnant and lactating ladies. – Patients with history of topical steroids during last 2 months & systemic steroids during last 6 months. – Patients with recent dental filling associated with the lesion or associated with recent drug administration. – Patient with uncontrolled diabetes, uncontrolled hypertension, or those with positive HCV ab or HBs Ag.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed salah abd-elhameed, principal investigator – Cairo University

References

Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. Review.

Greenberg G, Glick M. Burket's Oral Medicine: Diagnosis and Treatment. Hamilton, Ontario, BC Decker, 11th ed., 2008:90-1

Nosratzehi T, Arbabi-Kalati F, Hamishehkar H, Bagheri S. Comparison of the Effects of Curcumin Mucoadhesive Paste and Local Corticosteroid on the Treatment of Erosive Oral Lichen Planus Lesions. J Natl Med Assoc. 2018 Feb;110(1):92-97. doi: 10.1016/j.jnma.2017.01.011. Epub 2017 May 11.

Citations Reporting on Results

Chainani-Wu N, Silverman S Jr, Reingold A, Bostrom A, Mc Culloch C, Lozada-Nur F, Weintraub J. A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus. Phytomedicine. 2007 Aug;14(7-8):437-46. Epub 2007 Jul 2.

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