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

NCT03877679 | Unknown Phase 1 DMC

• 1 other identifier: OMED2:5:1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Oral Lichen Planus

Keywords

oral lichen planus; curcumin; IL-33; corticosteroids

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain

  4 weeks

Secondary Outcomes (2)

• clinical sign score

  Baseline , 2nd week and 4th week

• IL-33 level in saliva

  base line and 4th week

Study Arms (2)

turmeric paste

EXPERIMENTAL

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).

Drug: Turmeric paste

Triamcenolone in orabase

ACTIVE COMPARATOR

Triamcenolone + na ploycarboxylate

Drug: Triamcinolone

Interventions

Triamcinolone DRUG

Triamcenolone +napolycarboxylate

Also known as: Triamcenolone in orabase

Triamcenolone in orabase

Turmeric paste DRUG

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

Also known as: Curcumin

turmeric paste

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (4)

• 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. doi: 10.1089/107555303321223035.

  PMID: 12676044 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 29510851 BACKGROUND

• 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. doi: 10.1016/j.phymed.2007.05.003. Epub 2007 Jul 2.

  PMID: 17604143 RESULT

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone; Orabase; Curcumin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor (CS) and statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: March 18, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after study completion
• Access Criteria: pubmed