Evaluation of the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus
| Registry | NCT06119672 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, sequential, masking: double, treatment |
| Enrollment | 36 (Estimated) |
| Sponsor | October 6 University (Other); collaborators: Cairo University |
| Conditions | Oral Lichen Planus |
| Interventions | Probiotic Blend Oral capsules, Corticosteroids for Local Oral Treatment (Drug) |
| Dates | start 2023-05-01, primary completion 2023-10-30 (estimated), completion 2023-12-30 (estimated), first posted 2023-11-07, last updated 2023-11-07 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Oral Lichen Planus All trials of Probiotic Blend Oral capsules All trials of Corticosteroids for Local Oral Treatment
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| systemic probiotic (A) | Active comparator | Drug: Probiotic Blend Oral capsules; Drug: 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) | Active comparator | Drug: 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 |
Sex: All, ages: 20 Years to 75 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Cairo University | Cairo | Egypt | Recruiting |