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

The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (Randomized Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Lichen Planus, Oral
• Intervention / Treatment: Drug: Selenium; Drug: Triamcinolone Acetonide 0.1% Oint; Drug: Tacrollimus Topical; Drug: Selenium & Triamcinolone Acetonide 0.1% Oint; Drug: Selenium& Tacrollimus topical

Detailed Description

The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt, 0000
    • Alazhar university ,faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• clinical diagnosis of OLP

Exclusion Criteria:

1. lichenoid reaction from medication ' .
2. any systemic autoimmune disease
3. Pregnancy
4. smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group I (triamcinolone); 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; RCT; Other Names: Group I
Placebo Comparator: group II (tacrollimus); ten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks.	Drug: Tacrollimus Topical; RCT; Other Names: Group II
Experimental: group III (selenium); ten patients with oral lichen planus, will receive topical selenium four times per day for six weeks.	Drug: Selenium; RCT; Other Names: Group III
Experimental: group IV (selenium + triamcinolone ); : 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; RCT; Other Names: Group IV
Experimental: group V ( selenium + tacrollimus); 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; RCT; Other Names: Group V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to assess a visual analog scale (VAS)of the oral lichen planus lesion	qualitative	baseline, 1, 3 and 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis	qualitative ,and quantitiave	baseline, 1, 3 and 6 months after treatment
Biochemical evaluation of salivary Glutathione level using (ELISA)	Quantity	baseline, 1, 3 months after treatment

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Sphinx university

Publications and helpful links

Helpful Links

• ncbi
• orcid

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Antioxidant; Reactive oxygen species; seleinum; Glutathione-S-transferases
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lichen Planus; Lichen Planus, Oral; Pharmaceutical Preparations; Dosage Forms; Polycyclic Compounds; Inorganic Chemicals; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Elements; Chalcogens; Minerals; Triamcinolone Acetonide; Selenium; Ointments
• Other Study ID Numbers: AUAREC2023011-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All patients were recruited from the outpatient clinic of the Dermatology Department, Assiut University Hospitals, and referred to oral Medicine clinics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.
• IPD Sharing Time Frame: ready now
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

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