Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119672
• Other study ID #: 311122
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: October 6 University
• Contact: Amira Abdelwhab, lecturer
• Phone: 01007647877
• Email: amira.abdelwhab.dent[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• 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
• Corticosteroids for Local Oral Treatment
topical clobetasol probionate in orabase application 4 times daily

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
October 6 University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	size wound	thongprasom scale	0 , 2 weeks and 4 weeks
Primary	Pain in oral cavity	Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain	0 , 2 weeks and 4 weeks
Secondary	candidal load assessment	culturing technique in CFU unit	0 and 4 weeks