Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

Last updated: November 5, 2023
Sponsor: October 6 University
Overall Status: Active - Recruiting

Phase

3

Condition

Warts

Rash

Treatment

Probiotic Blend Oral capsules

Corticosteroids for Local Oral Treatment

Clinical Study ID

NCT06119672
311122
  • Ages 20-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients who are diagnosed with symptomatic lichen planus whether bullous erosive orerythematous oral lichen planus.
  • Male or female patient with age range between 20-75 years old were included.
  • medically free individuals

Exclusion

Exclusion Criteria:

  • the use of systemic antibiotics, corticosteroids or immunosuppressive agents withinfour 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

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Probiotic Blend Oral capsules
Phase: 3
Study Start date:
May 01, 2023
Estimated Completion Date:
December 30, 2023

Connect with a study center

  • Cairo University

    Cairo, +2
    Egypt

    Active - Recruiting

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