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Evaluation of Salivary Level of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03871114
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Mohamed Amr, Cairo University

Study Description
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Brief Summary:
Thirty patients will be recruited from the outpatient clinic of the faculty of dentistry.fifteen systemically healthy individuals with normal mucosa and fifteen atrophic/erosive oral lichen planus patients. Oral lichen planus patients will be treated with a topical steroid and miR-155 and IL-10 will be assessed in saliva before and after 4 weeks of topical steroids use

Condition or disease Intervention/treatment
Oral Lichen Planus Drug: Triamcinolone Acetonide in orabase

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Salivary Levels of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid
Actual Study Start Date : March 10, 2019
Actual Primary Completion Date : April 10, 2019
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Groups and Cohorts
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Group/Cohort Intervention/treatment
OLP patients
fifteen patients with atrophic /erosive OLP will receive treatment with topical triamcinolone acetonide in orabase 1mg/g 3 times /day and assessed every week for 4 weeks
 Drug: Triamcinolone Acetonide in orabase
treatment of OLP with topical steroid
Other Name: topical corticosteroid
Control group


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of salivary levels of miR-155 in OLP before treatment [ Time Frame: baseline ]
    assessment of miR-155 in saliva of patients with OLP before treatment

  2. Measurement of salivary levels of IL-10 in OLP before treatment [ Time Frame: baseline ]
    assessment of IL-10 in saliva of patients with OLP before treatment


Secondary Outcome Measures :
  1. Measurement of salivary levels of miR-155 in OLP after treatment [ Time Frame: 4 weeks ]
    assessment of miR-155 in saliva of patients with OLP after treatment

  2. Measurement of salivary levels of IL-10 in OLP after treatment [ Time Frame: 4 weeks ]
    assessment of IL-10 in saliva of patients with OLP after treatment


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with atrophic/erosive oral lichen planus
Criteria

Inclusion Criteria:

  • Patients clinically and histopathologically diagnosed as having atrophic/erosive OLP.
  • Patients free from any other oral lesions
  • cooperative patients who agrees to take the supplied medications.
  • Patients who are systemically healthy

Exclusion Criteria:

  • Patients suffering from any systemic disease.
  • Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
  • Treatment with any oral topical medications for at least four weeks prior to the study.
  • Pregnant and lactating women.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871114


Locations
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Egypt
Faculty of Dentistry
Cairo, Egypt, 11431
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Eman Mohamed Amr, Associate Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03871114    
Other Study ID Numbers: miR-155 OLP
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
 Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action