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

• ClinicalTrials.gov Identifier: NCT03877679
• Recruitment Status: Not yet recruiting
• First Posted: March 18, 2019
• Last Update Posted: March 18, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Mohamed salah abd-elhameed, Cairo University

Tracking Information

• First Submitted Date: September 24, 2018
• First Posted Date: March 18, 2019
• Last Update Posted Date: March 18, 2019
• Estimated Study Start Date: May 1, 2019
• Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2019)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 14, 2019)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients
• Official Title: 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

Brief Summary

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).

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

• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Outcome assessor (CS) and statistician

Primary Purpose: Treatment

• Condition: Oral Lichen Planus

Intervention

• Drug: Triamcinolone
  Triamcenolone +napolycarboxylate
  Other Name: Triamcenolone in orabase
• 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
  Other Name: Curcumin

Study Arms

• 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).
  Intervention: Drug: Turmeric paste
• Active Comparator: Triamcenolone in orabase
  Triamcenolone + na ploycarboxylate
  Intervention: Drug: Triamcinolone

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 14, 2019): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2020
• Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03877679
• Other Study ID Numbers: OMED2:5:1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All authors of this trial will have access to the final trial dataset.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: after study completion
• Access Criteria: pubmed

• Responsible Party: Mohamed salah abd-elhameed, Cairo University
• Study Sponsor: Cairo University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cairo University
• Verification Date: March 2019