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Completed

NCT Number: NCT06605911

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

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

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Al-Azhar university

Asyut, Ass, 0000, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

topical triamcinolone acetonide

Drug

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

Other names: Group I

Topical Curcumin

Drug

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

Other names: Group II

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.

Other names: Group III

Primary outcomes

  1. Assess Visual Analog Scale (VAS) of OLP lesion

    Time frame: 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)

  2. Assess Oral Disease Severity Score

    Time frame: 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 outcomes

  1. Biochemical analysis of salivary interlukin 6 level using (ELISA)

    Time frame: baseline ,1 ,3 months

    Quantity

Sponsors and collaborators

Lead sponsor

Shaymaa Hussein Rafat Kotb

Other

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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