Effect of Oral Zinc Supplementation as an Adjuvant to Topical Corticosteroid in Oral Lichen Planus Patients

NCT04278599 | Unknown Phase 4

• 1 other identifier: shagun257
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Lichen planus is an auto-immune, chronic inflammatory disease that affects mucosal and cutaneous tissue. Erosive and atrophic oral lichen planus (OLP) are difficult to manage because patients present with symptoms ranging from episodic pain to severe discomfort and they have the highest malignant transformation rate (MTR) amongst all the forms of OLP. Zinc is associated with regeneration of epithelium, wound healing and mediating T-lymphocyte function; all of which can lead to healing and re-epithelisation in the lesions of erosive OLP. Besides this, it also has anti-oxidant and anti-inflammatory properties, which lead to decrease in apoptosis and transformation into a malignant state. This study intends to evaluate the effect of oral zinc supplements as an adjuvant to the topical corticosteroid therapy in the treatment of OLP.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (4)

• Assessment of changes in size of the lesion

  Thongprasom score (TS) will be used to assess changes in the size of the lesion. Digital Vernier callipers will be used to measure the largest dimension of ulcers at baseline and at each follow-up visit.

  Baseline, 6 weeks and 3 months.

• Assessment of changes in pain and burning sensation of the lesion.

  Visual Analogue Scale (VAS) will be used to assess changes in pain and burning sensation of the lesion.

  Baseline, 6 weeks and 3 months

• Assessment of changes in changes in erythema and ulceration.

  Modified Oral Mucositis Index (MOMI)- will be used to assess changes in erythema and ulceration.

  Baseline, 6 weeks and 3 months

• Assessment of quality of life of the patient.

  Oral Health Impact Profile -14 index (OHIP-14) will be used to assess the quality of life of the patient.

  Baseline, 6 weeks and 3 months

Secondary Outcomes (3)

• Number of episodes of new lesions in the follow-up period.

  Baseline, 6 weeks and 3 months

• Adverse effects of oral zinc supplementation.

  Baseline, 6 weeks and 3 months

• Requirement for additional systemic steroid therapy.

  Baseline, 6 weeks and 3 months

Study Arms (2)

Test group

EXPERIMENTAL

The patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion.

Drug: Oral Zinc supplementation

Control group

PLACEBO COMPARATOR

The patients will be administered Placebo tablets for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion.

Drug: Oral placebo supplementation

Interventions

Oral Zinc supplementation DRUG

In the test group, the patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. They will also be will be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.

Also known as: Zinc Acetate

Test group

Oral placebo supplementation DRUG

In the control group, the patients will be administered Placebo tablets for 6 weeks from the baseline. They will also be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.

Also known as: Placebo

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically and histopathologically proven cases of erosive and atrophic OLP.
• Patients who are willing to participate in the study.

You may not qualify if:

• Patients with reticular form of OLP and OLP with muco-cutaneous involvement.
• Patients consuming drugs for the treatment of OLP in the past 6 months.
• Suspected lichenoid reaction associated with drugs and restorations.
• Patients whose histopathological findings indicate moderate to severe dysplasia.
• Patients with acquired and congenital immuno-deficiency disorders like AIDS, chemotherapy, addiction to injectable opioids like hemophilia and blood dialysis. These patients are excluded because of difficulty in their biopsy procedure, control of infection, possible interaction with clinical findings of OLP, and their potential doubtful cooperation.
• Patients with systemic diseases involving the gastro-intestinal tract.
• Known cases of Acrodermatitis enteropathica where difficulty in zinc absorption persists.
• Presence of factors that can alter the absorption of zinc like consumption of calcium tablets, iron supplements and high protein diet.
• Pregnancy and lactation phase
• Alcoholic patients, since alcoholism results in intracellular zinc deficiency.
• Recorded allergy to zinc and/or corticosteroids.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Zinc Acetate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Shagun Solanki

  Post Graduate Institute of Dental Sciences, Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Tewari

CONTACT

01262283876; principalpgidsrohtak@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: January 15, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

IN (1)