Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

Phase 3

Recruiting

• Conditions: Oral Lichen Planus
• Interventions: Drug: Probiotic Blend Oral capsules; Drug: Corticosteroids for Local Oral Treatment

• Registration Number: NCT06119672
• Lead Sponsor: October 6 University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-09-25
• Primary Completion: 2023-10-30
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-05
• Last Update Submitted: 2023-11-05
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
systemic probiotic (A)	Probiotic Blend Oral capsules	Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily
systemic probiotic (A)	Corticosteroids for Local Oral Treatment	Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily
topical corticosteroid (B)	Corticosteroids for Local Oral Treatment	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

Primary Outcome Measures

Name	Time	Method
size wound	0 , 2 weeks and 4 weeks	thongprasom scale
Pain in oral cavity	0 , 2 weeks and 4 weeks	Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain

Secondary Outcome Measures

Name	Time	Method
candidal load assessment	0 and 4 weeks	culturing technique in CFU unit

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt