The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus

NCT06362005 | Completed Phase 4 DMC

• 1 other identifier: AUAREC2023011-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.

Conditions

Lichen Planus, Oral

Keywords

seleinum; Antioxidant; Glutathione-S-transferases; Reactive oxygen species

Outcome Measures

Primary Outcomes (1)

• to assess a visual analog scale (VAS)of the oral lichen planus lesion

  qualitative

  baseline, 1, 3 and 6 months after treatment

Secondary Outcomes (2)

• to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis

  baseline, 1, 3 and 6 months after treatment

• Biochemical evaluation of salivary Glutathione level using (ELISA)

  baseline, 1, 3 months after treatment

Study Arms (5)

group I (triamcinolone)

PLACEBO COMPARATOR

ten patients with oral lichen planus, will receive topical triamcinolone acetonide 0.1% four times per day for six weeks.

Drug: Triamcinolone Acetonide 0.1% Oint

group II (tacrollimus)

PLACEBO COMPARATOR

ten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks.

Drug: Tacrollimus Topical

group III (selenium)

EXPERIMENTAL

ten patients with oral lichen planus, will receive topical selenium four times per day for six weeks.

Drug: Selenium

group IV (selenium + triamcinolone )

EXPERIMENTAL

: ten patients with oral lichen planus, will receive topical selenium combined with topical triamcinolone acetonide 0.1% three times per day for each for six weeks

Drug: Selenium & Triamcinolone Acetonide 0.1% Oint

group V ( selenium + tacrollimus)

EXPERIMENTAL

ten patients with oral lichen planus, will receive topical selenium combined with topical tacrolimus 0.1% three times per day for each for six weeks.

Drug: Selenium& Tacrollimus topical

Interventions

Triamcinolone Acetonide 0.1% Oint DRUG

RCT

Also known as: Group I

group I (triamcinolone)

Tacrollimus Topical DRUG

RCT

Also known as: Group II

group II (tacrollimus)

Selenium DRUG

RCT

Also known as: Group III

group III (selenium)

Selenium & Triamcinolone Acetonide 0.1% Oint DRUG

RCT

Also known as: Group IV

group IV (selenium + triamcinolone )

Selenium& Tacrollimus topical DRUG

RCT

Also known as: Group V

group V ( selenium + tacrollimus)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinical diagnosis of OLP

You may not qualify if:

• lichenoid reaction from medication ' .
• any systemic autoimmune disease
• Pregnancy
• smokers

Sponsors & Collaborators

• Al-Azhar University: lead
• Sphinx university: collaborator

Study Sites (1)

Alazhar university ,faculty of Dental Medicine

Asyut, 0000, Egypt

Location

Related Links

• orcid
• ncbi

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone Acetonide; Ointments; Selenium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations; Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturere of oral medicine ,periodontology departement

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: ready now

Locations

EG (1)