Clinical trial NCT06605911: Assessment of the Efficacy of Topical Curcumin in Treatment of Oral Lichen Planus
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Lichen Planus
Keywords: oral lichen planus
Immune mediated condition
Topical Curcumin
Interlukin 6
ELIZA
Topical triamcinolone acetonide
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess Visual Analog Scale (VAS) of OLP lesion
timeFrame: baseline ,1 ,3 months
measure: Assess Oral Disease Severity Score
timeFrame: at base line ,after 1,3 months
Secondary outcomes:
measure: Biochemical analysis of salivary interlukin 6 level using (ELISA)
timeFrame: baseline ,1 ,3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Al-Azhar university
state: Ass
Study officials:
affiliation: Al-AzharU
name: Mohamed F Edrees, prof
role: STUDY_DIRECTOR
References: