Micronutrients in Management of Symptomatic Oral Lichen Planus

Cairo University (CU)

Status: Completed

Conditions: Oral Lichen Planus

Treatments: Dietary Supplement: Zinc sulphate heptahydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04765267

OMED 3-7-2

Details and patient eligibility

About

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 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.

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

42 participants in 3 patient groups

Topical Corticosteroid with Systemic Zinc.

Active Comparator group

Description:

Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma

Treatment:

Dietary Supplement: Zinc sulphate heptahydrate

Topical Corticosteroid with Systemic Vitamin D

Active Comparator group

Description:

Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals

Treatment:

Dietary Supplement: Zinc sulphate heptahydrate

Topical Corticosteroid

Other group

Description:

Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm

Treatment:

Dietary Supplement: Zinc sulphate heptahydrate