NCT03793634

Brief Summary

Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and anticarcinogenesis effect with little side effects is the aim for the future treatment of OLP.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2019

Status
unknown

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

January 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

January 3, 2019

Last Update Submit

January 3, 2019

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

  • Pain using Numerical rating scale

    Pain measure using Numerical rating scale

    1 month

Secondary Outcomes (1)

  • clinical sign score

    1 month

Study Arms (2)

topical chamomile

EXPERIMENTAL

herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.

Drug: topical chamomile

Topical Triamcinolone Acetonide

ACTIVE COMPARATOR

topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.

Drug: topical chamomile

Interventions

topical chamomileDRUG

herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect

Topical Triamcinolone Acetonidetopical chamomile

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic OLP.
  • Patients with no history of taking corticosteroids for the last 6 months.
  • Patients who agree to take medication.
  • Medically free

You may not qualify if:

  • Patients with oral lesions other than OLP.
  • Lichenoid reaction .
  • Pregnant females and lactation.
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Chamomile extract

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The supervisor(AA) will be blind. The principle investigator(EN) will supply the patient with the treatment. The supervisor (AA) will assess the clinical parameters before treatment , between visits and at the end of the treatment. Statistician will be blind. Double - blind study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
11 saraya st - manial - cairo

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 4, 2019

Study Start

January 15, 2019

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

January 4, 2019

Record last verified: 2019-01