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

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Cairo University
RECRUITING
Cairo
Contact Information
Primary
Amira Abdelwhab, lecturer
amira.abdelwhab.dent@o6u.edu.eg
01007647877
Time Frame
Start Date: 2023-05-01
Completion Date: 2023-12-30
Participants
Target number of participants: 36
Treatments
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
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
Related Therapeutic Areas
Sponsors
Collaborators: Cairo University
Leads: October 6 University

This content was sourced from clinicaltrials.gov