Clinical trial

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

NCT06119672

Name

311122

Description

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 arms

Trial start

2023-05-01

Estimated PCD

2023-10-30

Trial end

2023-12-30

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

systemic probiotic (A)

Corticosteroids for Local Oral Treatment

topical clobetasol probionate in orabase application 4 times daily

Arms:

systemic probiotic (A), topical corticosteroid (B)

Other names:

clobetasol probionate in orabase

Size

Primary endpoint

size wound

0 , 2 weeks and 4 weeks

Pain in oral cavity

0 , 2 weeks and 4 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

Updated at

2023-11-07

1 organization

2 products

1 indication

Organization

Product

Indication

Product