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

• ClinicalTrials.gov Identifier: NCT03738176
• Recruitment Status: Unknown
• First Posted: November 13, 2018
• Last Update Posted: August 2, 2019
• Sponsor: Mona Taha Mohammed MD
• Information provided by (Responsible Party): Mona Taha Mohammed MD, Cairo University

Study Description

Brief Summary:

use seseme oil and corticosteroid topically for two groups

Condition or disease	Intervention/treatment	Phase
Oral Lichen Planus	Drug: Sesame Oil; Drug: triamcinolone in orabase	Early Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: sesame oil in orabase(80 gm CMC -20 gm sesame oil)
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Topical Sesame Oil in Orabase Versus Topical Triamcinolone in Orabase on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker, Malondialdehyde [MDA] : Randomized Clinical Trial (RCT)
• Estimated Study Start Date: December 16, 2019
• Estimated Primary Completion Date: November 16, 2020
• Estimated Study Completion Date: December 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: sesame oil in orabase; 20 gm sesame oil-80 gm CMC 3 times per day for one month	Drug: Sesame Oil; Sesame oil(80 gm NaCMC-20 gmSesame oil); Other Name: sesame oil gel
Active Comparator: triamcinolone in orabase; 140 gm triamcinolone-50 gm Na CMC 3 times per day for one month	Drug: triamcinolone in orabase; triamcinolone 140 gm-Na CMC 50 gm; Other Name: kenacorte

Outcome Measures

Primary Outcome Measures :

1. pain intensit measure [ Time Frame: 4 weeks ]
   measured by visual analogue scale where0 no pain and 10 sever pain
2. reduction of clinical signs measure [ Time Frame: 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 :

1. Salivary level of oxidative stress biomarker (MDA) [ Time Frame: 4 weeks ]
   measured by reaction with thiobarbituric acid (TBA)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Mona Taha Mohammed Ahamed, Master; 01123294474; mona.taha@dentistry.cu.edu.eg

Contact: Amal ALI Ali, LEcturer; 01156520918; amal.ali@dentistry.cu.edu.eg

Sponsors and Collaborators

Mona Taha Mohammed MD

Investigators

• Principal Investigator: Mona Taha Mohammed Ahammed, MD; Cairo U

More Information

• Responsible Party: Mona Taha Mohammed MD, clinical researcher, Cairo University
• ClinicalTrials.gov Identifier: NCT03738176
• Other Study ID Numbers: 2:5:1
• First Posted: November 13, 2018
• Last Update Posted: August 2, 2019
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mona Taha Mohammed MD, Cairo University:

Oral lichen planus; sesame oil; corticosteroid; MDA

Additional relevant MeSH terms:

Lichen Planus, Oral; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Mouth Diseases; Stomatognathic Diseases; Triamcinolone; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs