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

Phase 1

• Conditions: Oral Lichen Planus
• Interventions: Drug: Turmeric paste; Drug: Triamcinolone

• Registration Number: NCT03877679
• Lead Sponsor: Cairo University

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 Timeline

• Study First Submitted: 2018-09-24
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Study First Posted: 2019-03-18
• Last Update Posted: 2019-03-18
• Study Start: 2019-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
turmeric paste	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).
Triamcenolone in orabase	Triamcinolone	Triamcenolone + na ploycarboxylate

Primary Outcome Measures

Name	Time	Method
Pain intensity	4 weeks	measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain

Secondary Outcome Measures

Name	Time	Method
clinical sign score	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	base line and 4th week	by ELISA