Assessment of the Efficacy of Topical Curcumin in Treatment of Oral Lichen Planus

Phase 3

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: topical triamcinolone acetonide; Drug: Topical Curcumin; Drug: topical triamcinolone acetonide combiend with topical curcumin

• Registration Number: NCT06605911
• Lead Sponsor: Shaymaa Hussein Rafat Kotb

Brief Summary

to evaluate the therapeutic impact of curcumin as Alternative or Complementary to Triamcinolone Acetonate in Treatment of Oral Lichen Planus.

Detailed Description

Background: Oral lichen planus (OLP) is a chronic inflammatory disorder affecting the mucous membranes, believed to be an immune-mediated condition. Its persisting nature can lead to extended discomfort for those affected. The primary symptoms are pain and a burning sensation, with a potential risk of malignancy if not properly managed, necessitating lifelong clinical monitoring. Presently, OLP is considered a significant challenge due to the absence of a definitive cure.

Patients \& patients: Thirty patients with oral lichen planus were divided into three groups, 10 patients each: Group A: ten patients with OLP were received topical triamcinolone acetonide. Group B: ten patients with OLP were received topical curcumin. Group C: ten patients with oral lichen planus were received topical triamcinolone acetonide combiend with topical curcumin. For six weeks. Each patient was examined at baseline,1 and 3months of therapy. Pain was scored using the visual analogue scale. Salivary level of interleukin 1 were estimated at baseline,1and 3 months' evaluation periods.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-08-01
• Study Completion: 2024-06-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-20
• Last Update Posted: 2024-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• clinical diagnosis of OLP

Exclusion Criteria

• Any systemic autoimmune disease
• Any current use of anticoagulant or antiplatelet agents (curcumin has inhibitory effects on platelet aggregations).
• Any topical, local or systemic corticosteroids therapy during the past 3 months.
• lichenoid reaction from medications.
• Pregnant or lactation women.
• smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical triamcinolone acetonide	topical triamcinolone acetonide	Group I
Topical curcumin	Topical Curcumin	Group II
Topical triamcinolone acetonide combiend with topical curcumin	topical triamcinolone acetonide combiend with topical curcumin	Group III

Primary Outcome Measures

Name	Time	Method
Assess Visual Analog Scale (VAS) of OLP lesion	baseline ,1 ,3 months	Qualitative.P-value \>0.05: Non significant(NS); P-value \<0.05: Significant(S); P-value\< 0.01: highly significant(HS)
Assess Oral Disease Severity Score	at base line ,after 1,3 months	Qualitative.P-value \>0.05: Non significant(NS); P-value \<0.05: Significant(S); P-value\< 0.01: highly significant(HS)

Secondary Outcome Measures

Name	Time	Method
Biochemical analysis of salivary interlukin 6 level using (ELISA)	baseline ,1 ,3 months	Quantity

Trial Locations

Locations (1)

Al-Azhar university; 🇪🇬 Assiut, Ass, Egypt