Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

November 5, 2023 updated by: Amira Abdelwhab, October 6 University

Evaluation of the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: systemic probiotic (A)
Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily
Drug: Probiotic Blend Oral capsules
probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily
Drug: Corticosteroids for Local Oral Treatment
topical clobetasol probionate in orabase application 4 times daily
Other Names:
  • clobetasol probionate in orabase
Active Comparator: topical corticosteroid (B)
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
topical clobetasol probionate in orabase application 4 times daily
Other Names:
  • clobetasol probionate in orabase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
size wound
Time Frame: 0 , 2 weeks and 4 weeks
thongprasom scale
0 , 2 weeks and 4 weeks
Pain in oral cavity
Time Frame: 0 , 2 weeks and 4 weeks
Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain
0 , 2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
candidal load assessment
Time Frame: 0 and 4 weeks
culturing technique in CFU unit
0 and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Collaborators

Cairo University

Investigators

  • Principal Investigator: yasmine kamal, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 311122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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