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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 3, 2019
    Last Updated
    January 3, 2019
    Sponsor
    Cairo University
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    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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