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

NCT06605911 | Completed Phase 3 DMC

• 1 other identifier: AUAREC20240004-15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Lichen Planus

Keywords

oral lichen planus; Immune mediated condition; Topical Curcumin; Interlukin 6; ELIZA; Topical triamcinolone acetonide

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Biochemical analysis of salivary interlukin 6 level using (ELISA)

  baseline ,1 ,3 months

Study Arms (3)

Topical triamcinolone acetonide

EXPERIMENTAL

Group I

Drug: topical triamcinolone acetonide

Topical curcumin

EXPERIMENTAL

Group II

Drug: Topical Curcumin

Topical triamcinolone acetonide combiend with topical curcumin

ACTIVE COMPARATOR

Group III

Drug: topical triamcinolone acetonide combiend with topical curcumin

Interventions

topical triamcinolone acetonide DRUG

ten patients with OLP were received topical triamcinolone acetonide four times per day for six weeks

Also known as: Group I

Topical triamcinolone acetonide

Topical Curcumin DRUG

Ten patients with OLP received topical curcumin four times per day for six weeks.

Also known as: Group II

Topical curcumin

topical triamcinolone acetonide combiend with topical curcumin DRUG

Ten patients with OLP received a combination of topical triamcinolone acetonide and topical curcumin four times per day for six weeks.

Also known as: Group III

Topical triamcinolone acetonide combiend with topical curcumin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of OLP

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaymaa Hussein Rafat Kotb: lead

Study Sites (1)

Al-Azhar university

Asyut, Ass, 0000, Egypt

Location

Related Links

• Orchid

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone Acetonide; 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)

Triamcinolone; 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 Officials

• Mohamed F Edrees, prof

  Al-AzharU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of Oral Medicine ,periodontology ,oral Diagnosis &amp; Dental Radiology ,Sphinx university

Model Details: 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, 2, weeks and 1 and 3months of therapy. Pain was scored using the visual analogue scale. Salivary level of interleukin 1 were estimated at baseline, 1 and3 months' evaluation periods.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 20, 2024
• Study Start: June 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: June 1, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

EG (1)