The Efficacy of Topical Sesame Oil Versus Topical Triamcinolone on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker [MDA]

Early Phase 1

• Conditions: Oral Lichen Planus
• Interventions: Drug: triamcinolone in orabase; Drug: Sesame Oil

• Registration Number: NCT03738176
• Lead Sponsor: Mona Taha Mohammed MD

Brief Summary

use seseme oil and corticosteroid topically for two groups

Detailed Description

* The enrolled patients will be divided randomly into two groups.

* Test group will receive topical sesame oil (3 times /day after eating) for a month.

* Control group will receive topical corticosteroid (3 times /day after eating) for a month.

* Assessment of the appearance score and severity of pain as well as the clinical parameter outcome will be done at baseline and at the end of two and four weeks and will be recorded in the patients' questionnaires \& by clinical sign score . MDA will be measured at the baseline \& at the end of four weeks after treatment.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-02
• Study Start: 2019-12-16
• Primary Completion: 2020-11-16
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients who will be clinically diagnosed as having atrophic &/or erosive oral lichen planus.

  • Patients with no history of taking topical corticosteroids for the last 2 months and systemic corticosteroid for the last 6 months
  • Patients who agree to take medication and follow up .

Exclusion Criteria

• Pregnant and lactating ladies.

  • Patients with history of topical steroids during last 2 months & systemic steroids during last 6 months.
  • Patients with recent dental filling associated with the lesion or associated with recent drug administration.
  • Patient with history of diabetes or hypertension or those with positive HCV ab or HBs Ag.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
triamcinolone in orabase	triamcinolone in orabase	140 gm triamcinolone-50 gm Na CMC 3 times per day for one month
sesame oil in orabase	Sesame Oil	20 gm sesame oil-80 gm CMC 3 times per day for one month

Primary Outcome Measures

Name	Time	Method
pain intensit measure	4 weeks	measured by visual analogue scale where0 no pain and 10 sever pain
reduction of clinical signs measure	4 weeks	Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area \< 1 cm2 Score 3 = white striae with erosive area \> 1 cm2 Score 2 = white striae with atrophic area \< 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal

Secondary Outcome Measures

Name	Time	Method
Salivary level of oxidative stress biomarker (MDA)	4 weeks	measured by reaction with thiobarbituric acid (TBA)