Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus
Primary Purpose
Oral Lichen Planus
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
topical chamomile
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
topical chamomile
Topical Triamcinolone Acetonide
Arm Description
herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.
topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.
Outcomes
Primary Outcome Measures
Pain using Numerical rating scale
Pain measure using Numerical rating scale
Secondary Outcome Measures
clinical sign score
Reduction in clinical sign score using Thongprasom et al
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03793634
Brief Title
Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus
Official Title
Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The supervisor(AA) will be blind. The principle investigator(EN) will supply the patient with the treatment.
The supervisor (AA) will assess the clinical parameters before treatment , between visits and at the end of the treatment.
Statistician will be blind. Double - blind study.
Allocation
Randomized
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
topical chamomile
Arm Type
Experimental
Arm Description
herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.
Arm Title
Topical Triamcinolone Acetonide
Arm Type
Active Comparator
Arm Description
topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.
Intervention Type
Drug
Intervention Name(s)
topical chamomile
Intervention Description
herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect
Primary Outcome Measure Information:
Title
Pain using Numerical rating scale
Description
Pain measure using Numerical rating scale
Time Frame
1 month
Secondary Outcome Measure Information:
Title
clinical sign score
Description
Reduction in clinical sign score using Thongprasom et al
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus
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