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Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

Sponsor
October 6 University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06119672
Collaborator
Cairo University (Other)
36
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Probiotic Blend Oral capsules
  • Drug: Corticosteroids for Local Oral Treatment
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. size wound [0 , 2 weeks and 4 weeks]

      thongprasom scale

    2. Pain in oral cavity [0 , 2 weeks and 4 weeks]

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

    Secondary Outcome Measures

    1. candidal load assessment [0 and 4 weeks]

      culturing technique in CFU unit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt +2

    Sponsors and Collaborators

    • October 6 University
    • Cairo University

    Investigators

    • Principal Investigator: yasmine kamal, lecturer, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Abdelwhab, lecturer, October 6 University
    ClinicalTrials.gov Identifier:
    NCT06119672
    Other Study ID Numbers:
    • 311122
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Amira Abdelwhab, lecturer, October 6 University
    oral lichen planus
    probiotics
    clobetasol probionate
    Additional relevant MeSH terms:
    Lichen Planus, Oral
    Lichen Planus
    Clobetasol

    Study Results

    No Results Posted as of Nov 7, 2023