Micronutrients in Management of Symptomatic Oral Lichen Planus
Primary Purpose
Oral Lichen Planus
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Zinc sulphate heptahydrate
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring micronutrients, topical corticosteroids
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from erosive or atrophic OLP
- Patients free from any visible oral lesions other than OLP.
- Patients who agreed to take the supplied interventions.
- Patient who will agree to participate in the study.
- Patients who will accept to sign the informed consent.
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 mothers.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Topical Corticosteroid with Systemic Zinc.
Topical Corticosteroid with Systemic Vitamin D
Topical Corticosteroid
Arm Description
Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma
Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals
Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm
Outcomes
Primary Outcome Measures
Change in pain intensity
Visual analogue scale (0-10)
Secondary Outcome Measures
change in clinical improvement
measured using Thongprasom et al. scoring system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04765267
Brief Title
Micronutrients in Management of Symptomatic Oral Lichen Planus
Official Title
Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh & Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.
Detailed Description
The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
micronutrients, topical corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topical Corticosteroid with Systemic Zinc.
Arm Type
Active Comparator
Arm Description
Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma
Arm Title
Topical Corticosteroid with Systemic Vitamin D
Arm Type
Active Comparator
Arm Description
Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals
Arm Title
Topical Corticosteroid
Arm Type
Other
Arm Description
Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc sulphate heptahydrate
Other Intervention Name(s)
Cholecalciferol: vitamin D3 oral solution
Intervention Description
Dietary supplements
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
Visual analogue scale (0-10)
Time Frame
baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7
Secondary Outcome Measure Information:
Title
change in clinical improvement
Description
measured using Thongprasom et al. scoring system
Time Frame
baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering from erosive or atrophic OLP
Patients free from any visible oral lesions other than OLP.
Patients who agreed to take the supplied interventions.
Patient who will agree to participate in the study.
Patients who will accept to sign the informed consent.
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 mothers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
alaa a mohamed, assistant lecturer
Phone
+201005875212
Email
alaa_shousha@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
ZIP/Postal Code
11728
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
alaa a mohamed
Phone
+201005875212
Email
alaa_shousha@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Micronutrients in Management of Symptomatic Oral Lichen Planus
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