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

NCT03738176 | Unknown Early Phase 1

• 1 other identifier: 2:5:1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

use seseme oil and corticosteroid topically for two groups

Conditions

Oral Lichen Planus

Keywords

Oral lichen planus; sesame oil; corticosteroid; MDA

Outcome Measures

Primary Outcomes (2)

• pain intensit measure

  measured by visual analogue scale where0 no pain and 10 sever pain

  4 weeks

• reduction of clinical signs measure

  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

  4 weeks

Secondary Outcomes (1)

• Salivary level of oxidative stress biomarker (MDA)

  4 weeks

Study Arms (2)

sesame oil in orabase

EXPERIMENTAL

20 gm sesame oil-80 gm CMC 3 times per day for one month

Drug: Sesame Oil

triamcinolone in orabase

ACTIVE COMPARATOR

140 gm triamcinolone-50 gm Na CMC 3 times per day for one month

Drug: triamcinolone in orabase

Interventions

Sesame Oil DRUG

Sesame oil(80 gm NaCMC-20 gmSesame oil)

Also known as: sesame oil gel

sesame oil in orabase

triamcinolone in orabase DRUG

triamcinolone 140 gm-Na CMC 50 gm

Also known as: kenacorte

triamcinolone in orabase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mona Taha Mohammed MD: lead

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Sesame Oil; Triamcinolone; Orabase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Mona Taha Mohammed Ahammed, MD

  Cairo U

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Taha Mohammed Ahamed, Master

CONTACT

01123294474; mona.taha@dentistry.cu.edu.eg

Amal ALI Ali, LEcturer

CONTACT

01156520918; amal.ali@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical researcher

Model Details: sesame oil in orabase(80 gm CMC -20 gm sesame oil)

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: December 16, 2019
• Primary Completion: November 16, 2020
• Study Completion: December 30, 2020
• Last Updated: August 2, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share