Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus

Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and anticarcinogenesis effect with little side effects is the aim for the future treatment of OLP.

Study Overview

• Status: Unknown
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: topical chamomile

Detailed Description

Oral lichen planus (OLP) is a chronic inflammatory T cell mediated autoimmune disease that affects skin and any mucous membrane particularly oral mucosa.The patient complains of burning sensation, pain; interference with eating, swallowing and speech leading to worsening of quality of life.Oxidative stress plays a role in pathomechanism of OLP disease. Enzymatic and non- enzymatic anti-oxidants act as a physiological guard against reactive oxygen species (ROS) and cytokine-mediated toxicity.Herbal treatment is the aim of the future therapy.Chamomile has anti-oxidant , anti-inflammatory effect and accelerate healing.

• Study Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic OLP.
• Patients with no history of taking corticosteroids for the last 6 months.
• Patients who agree to take medication.
• Medically free

Exclusion Criteria:

• Patients with oral lesions other than OLP.
• Lichenoid reaction .
• Pregnant females and lactation.
• Smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: topical chamomile; herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.	Drug: topical chamomile; herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect
Active Comparator: Topical Triamcinolone Acetonide; topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.	Drug: topical chamomile; herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain using Numerical rating scale	Pain measure using Numerical rating scale	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical sign score	Reduction in clinical sign score using Thongprasom et al	1 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus
• Other Study ID Numbers: chamomile in OLP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes