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.
Full Title of Study: “Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: April 1, 2023
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.
- Dietary Supplement: Zinc sulphate heptahydrate
- Dietary supplements
Arms, Groups and Cohorts
- Active Comparator: Topical Corticosteroid with Systemic Zinc.
- Octozinc: Zinc sulphate heptahydrate 25 mg tablets – October Pharma
- Active Comparator: Topical Corticosteroid with Systemic Vitamin D
- Cholecalciferol: vitamin D3 15 ml oral solution – Medical Union Pharmaceuticals
- Other: Topical Corticosteroid
- Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste – Dermapharm
Clinical Trial Outcome Measures
- Change in pain intensity
- Time Frame: baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7
- Visual analogue scale (0-10)
- change in clinical improvement
- Time Frame: baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7
- measured using Thongprasom et al. scoring system
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Cairo University
- Provider of Information About this Clinical Study
- Principal Investigator: Alaa Shousha, Assistant Lecturer – Cairo University
- Overall Contact(s)
- alaa a mohamed, assistant lecturer, +201005875212, firstname.lastname@example.org
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