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311122

Efficacy of probiotic capsules with topical clobetasol propionate in olp treatment
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06119672
oral lichen planus
probiotics
clobetasol probionate
Source : Importé depuis le centre
Oral Lichen Planus
Recrutement ouvert
Dernière modification : 2023/11/08
Type de recherche

Interventionnel

Médicament expérimental

Phase 3


Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Oral Lichen Planus

Source : Importé depuis le centre

Profil des participants

Sexe(s) des participants

All

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

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

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
systemic probiotic (A) Donnée non disponible Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily
  • Inconnu
  • topical corticosteroid (B) Donnée non disponible 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
  • Inconnu
  • systemic probiotic (A)
    État du recrutement
    unknown
    topical corticosteroid (B)
    État du recrutement
    unknown
    Données à jour depuis : 8 novembre 2023

    Description de l'étude

    Résumé de l'étude

    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.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 8 novembre 2023
    Données à jour depuis : 31 juil.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06119672