Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for Erosive Oral Lichen Planus (a Randomized, Controlled Clinical Trial)

Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell mediated autoimmune disorder.

Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the antioxidant defense system. In addition, this mineral protects cells against inflammation by oxidative stress, because it acts in the stabilization of cell membrane. It also maintains macrophage and neutrophil functions, natural killer cell activity, and complement activity.

Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of (MMP-9).

Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50 mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of erosive OLP.

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Oral zinc supplement; Drug: triamcinolone acetonide Oral paste

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients involved in this clinical trial will have symptomatic OLP

Exclusion Criteria:

• Smokers or tobacco users will be excluded from this clinical trial.
• Pregnant and lactating females.
• Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study.
• Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded.
• Any patients presenting with extra oral lichen planus lesions will be excluded.
• Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded.
• Vitamin administration intake within the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Drug: triamcinolone acetonide Oral paste; patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.
Experimental: Test group	Drug: Oral zinc supplement; patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oral lesions	Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 assigned to patients with white striae and erosive areas <1 cm2, score 3 assigned to those having white striae and atrophic areas >1 cm2, score 2 assigned to those having white striae and atrophic areas <1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa.	Baseline, 6 weeks, 12 weeks
Change in MMP-9 level	Whole unstimulated saliva will be collected from all participants	Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Patients will be asked to assign a numerical score representing the intensity of their symptoms on a scale from 0 to 10, with 0 being no symptoms and 10 being worst imaginable symptoms	Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): February 14, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: Oral medicine_0424-04\2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No