Thyme Honey for Management of Oral Lichen Planus

Thyme Honey for Management of Oral Lichen Planus: A Non- Inferiority Controlled Randomized Clinical Trial

the study aimed to assess the effect of topical application of thyme honey in comparison to 0.1% triamcinolone acetonide oral paste on the relief of pain and clinical improvement in patients with OLP

Study Overview

• Status: Enrolling by invitation
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Dietary supplement: thyme honey; Drug: Triamcinolone Acetonide

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • The british university in egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:• Patients clinically and histopathologically (if required) diagnosed as suffering from OLP.

• Patients free from any visible oral lesions other than OLP.
• Patients who agreed to take supplied medications.
• Patients who agreed for the biopsy (when required).

Exclusion Criteria:• •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 women.
• In addition, no consideration was given to patients with a history of hypersensitivity to honey.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thyme Honey group; Topical application of Thyme Honey	Dietary supplement: thyme honey; Topical application on the oral mucosa
Placebo Comparator: Control group; Topical application of Triamcinolone acetonide	Drug: Triamcinolone Acetonide; Topical application on the oral mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score assessement	Pain intensity	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
measurement of salivary level of miRna155	1 month

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Oral Lichen Planus; Thyme Honey; triamcinolone acteonide
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Lichen Planus, Oral; Lichen Planus; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 24-092

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes