NCT06119672

Brief Summary

Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups

  • The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks. Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment . Patient's visits was at baseline, 2 weeks and 4 weeks.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

September 25, 2023

Last Update Submit

November 5, 2023

Conditions

Oral Lichen Planus

Keywords

oral lichen planusprobioticsclobetasol probionate

Outcome Measures

Primary Outcomes (2)

  • size wound

    thongprasom scale

    0 , 2 weeks and 4 weeks

  • Pain in oral cavity

    Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain

    0 , 2 weeks and 4 weeks

Secondary Outcomes (1)

  • candidal load assessment

    0 and 4 weeks

Study Arms (2)

systemic probiotic (A)

ACTIVE COMPARATOR

Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily

Drug: Probiotic Blend Oral capsulesDrug: Corticosteroids for Local Oral Treatment

topical corticosteroid (B)

ACTIVE COMPARATOR

topical clobetasol in orabse application will be given 4 times daily ( 3 times after meals and once before bed time) prophylactic topical antifungal will be given in the fourth week to prevent candidal infection

Drug: Corticosteroids for Local Oral Treatment

Interventions

Probiotic Blend Oral capsulesDRUG

probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily

systemic probiotic (A)
Corticosteroids for Local Oral TreatmentDRUG

topical clobetasol probionate in orabase application 4 times daily

Also known as: clobetasol probionate in orabase
systemic probiotic (A)topical corticosteroid (B)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus.
  • Male or female patient with age range between 20-75 years old were included.
  • medically free individuals

You may not qualify if:

  • the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study.
  • Pregnant females
  • patients with history of systemic disorder affecting the immune system
  • active liver diseases and cancer
  • allergy or intolerance to probiotics.
  • any other oral lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, +2, Egypt

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Adrenal Cortex HormonesOrabase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • yasmine kamal, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Abdelwhab, lecturer

CONTACT

01007647877amira.abdelwhab.dent@o6u.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 25, 2023

First Posted

November 7, 2023

Study Start

May 1, 2023

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)