NCT04765267

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration 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

First Submitted

Initial submission to the registry

February 4, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.4 years

First QC Date

February 4, 2021

Last Update Submit

November 5, 2023

Conditions

Oral Lichen Planus

Keywords

micronutrientstopical corticosteroids

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity

    Visual analogue scale (0-10)

    baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7

Secondary Outcomes (1)

  • change in clinical improvement

    baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7

Study Arms (3)

Topical Corticosteroid with Systemic Zinc.

ACTIVE COMPARATOR

Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma

Dietary Supplement: Zinc sulphate heptahydrate

Topical Corticosteroid with Systemic Vitamin D

ACTIVE COMPARATOR

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

Dietary Supplement: Zinc sulphate heptahydrate

Topical Corticosteroid

OTHER

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

Dietary Supplement: Zinc sulphate heptahydrate

Interventions

Zinc sulphate heptahydrateDIETARY_SUPPLEMENT

Dietary supplements

Also known as: Cholecalciferol: vitamin D3 oral solution
Topical CorticosteroidTopical Corticosteroid with Systemic Vitamin DTopical Corticosteroid with Systemic Zinc.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 11728, Egypt

Location

Related Publications (1)

  • Aboushousha A, Kamal Y, Ali S. Supplementary zinc and vitamin D in management of symptomatic oral lichen planus: a three-arm randomized clinical trial. BMC Oral Health. 2025 Jun 2;25(1):872. doi: 10.1186/s12903-025-06173-1.

    PMID: 40457259DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Zinc SulfateCholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc CompoundsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 21, 2021

Study Start

April 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)