Micronutrients in Management of Symptomatic Oral Lichen Planus

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04765267

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Lichen Planus	Dietary Supplement: Zinc sulphate heptahydrate	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Topical Corticosteroid with Systemic Zinc. Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma	Dietary Supplement: Zinc sulphate heptahydrate Dietary supplements Other Names: Cholecalciferol: vitamin D3 oral solution
Active Comparator: Topical Corticosteroid with Systemic Vitamin D Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals	Dietary Supplement: Zinc sulphate heptahydrate Dietary supplements Other Names: Cholecalciferol: vitamin D3 oral solution
Other: Topical Corticosteroid Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm	Dietary Supplement: Zinc sulphate heptahydrate Dietary supplements Other Names: Cholecalciferol: vitamin D3 oral solution

Arm

Intervention/Treatment

Active Comparator: Topical Corticosteroid with Systemic Zinc.

Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma

Dietary Supplement: Zinc sulphate heptahydrate

Dietary supplements

Other Names:

Cholecalciferol: vitamin D3 oral solution

Active Comparator: Topical Corticosteroid with Systemic Vitamin D

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

Dietary Supplement: Zinc sulphate heptahydrate

Dietary supplements

Other Names:

Cholecalciferol: vitamin D3 oral solution

Other: Topical Corticosteroid

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

Dietary Supplement: Zinc sulphate heptahydrate

Dietary supplements

Other Names:

Cholecalciferol: vitamin D3 oral solution

Outcome Measures

Primary Outcome Measures

Change in pain intensity [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)

Secondary Outcome Measures

change in clinical improvement [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.