NCT06810752

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

October 12, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 6, 2025

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

January 23, 2025

Last Update Submit

February 4, 2025

Conditions

Oral Lichen Planus

Keywords

Oral Lichen PlanusThyme Honeytriamcinolone acteonide

Outcome Measures

Primary Outcomes (1)

  • VAS score assessement

    Pain intensity

    1 month

Secondary Outcomes (1)

  • measurement of salivary level of miRna155

    1 month

Study Arms (2)

Thyme Honey group

ACTIVE COMPARATOR

Topical application of Thyme Honey

Dietary Supplement: thyme honey

Control group

PLACEBO COMPARATOR

Topical application of Triamcinolone acetonide

Drug: Triamcinolone Acetonide

Interventions

thyme honeyDIETARY_SUPPLEMENT

Topical application on the oral mucosa

Thyme Honey group
Triamcinolone AcetonideDRUG

Topical application on the oral mucosa

Control group

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The British university in Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 6, 2025

Study Start

October 12, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

February 6, 2025

Record last verified: 2024-10

Locations

EG(1)