drugset / Trial / NCT06119672

Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

NCT06119672 ↗

Phase 3 Unknown 36 enrolled October 6 University Cairo University · collab
RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2023-05-01
Primary completion
2023-10-30
Completion
2023-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Probiotic Blend Unknown — Oral
Comparator clobetasol probionate Unknown — Topical

Indications