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

Assessment of the Efficacy of Topical Applied Curcumin 1% as Alternative or Complementary to Triamcinolone Acetonate in Treatment of Oral Lichen Planus(Randomise Control Trial)

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

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: topical triamcinolone acetonide; Drug: Topical Curcumin; Drug: topical triamcinolone acetonide combiend with topical curcumin

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Ass
    • Assiut, Ass, Egypt, 0000
      • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical triamcinolone acetonide; Group I	Drug: topical triamcinolone acetonide; ten patients with OLP were received topical triamcinolone acetonide four times per day for six weeks; Other Names: Group I
Experimental: Topical curcumin; Group II	Drug: Topical Curcumin; Ten patients with OLP received topical curcumin four times per day for six weeks.; Other Names: Group II
Active Comparator: Topical triamcinolone acetonide combiend with topical curcumin; Group III	Drug: topical triamcinolone acetonide combiend with topical curcumin; Ten patients with OLP received a combination of topical triamcinolone acetonide and topical curcumin four times per day for six weeks.; Other Names: Group III

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical analysis of salivary interlukin 6 level using (ELISA)	Quantity	baseline ,1 ,3 months

Collaborators and Investigators

• Sponsor: Shaymaa Hussein Rafat Kotb
• Investigators: Study Director: Mohamed F Edrees, prof, Al-AzharU

Publications and helpful links

Helpful Links

• Orchid

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: oral lichen planus; Immune mediated condition; Topical Curcumin; Interlukin 6; ELIZA; Topical triamcinolone acetonide
• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Curcumin
• Other Study ID Numbers: AUAREC20240004-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No