NCT06042010

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

September 12, 2023

Last Update Submit

September 12, 2023

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Change in pain

    Baseline, 6 weeks, 12 weeks

Study Arms (2)

Test group

EXPERIMENTAL
Drug: Oral zinc supplement

control group

ACTIVE COMPARATOR
Drug: triamcinolone acetonide Oral paste

Interventions

Oral zinc supplementDRUG

patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%

Test group
triamcinolone acetonide Oral pasteDRUG

patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.

control group

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 18, 2023

Study Start

January 5, 2023

Primary Completion

February 14, 2023

Study Completion

February 14, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

EG(1)