Effects of two mucoadhesive forms of Clobetasol on oral lichen planus

Phase 3

• Conditions: Oral lichen planus.; Lichen planus

• Registration Number: IRCT20200425047195N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Diagnosis of oral lichen planus according to clinical criterias and histopathology
The age range: 16-70 years old
Non-use of local or systemic drugs to treatment of lichen planus (one week before start of the study)
Severity of lesions with 3, 4, and 5 scores according to Thongprasom index
Non-use of immunosuppressive drugs (one week before start of the study)
Non-use of drugs which cause lichenoid reaction (one week before start of the study)

Exclusion Criteria

Pregnancy and breastfeeding
Use of drugs which cause lichenoid reaction
Use of immunosuppressive drugs
Existence of any systemic disease other than lichen planus (example: viral, bacterial, and fungal infections; acute peptic ulcer; acute glomerulonephritis; myasthenia gravis)
Existence of lesions in direct contact with amalgam-treated teeth
Allergy to corticosteroids

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity. Timepoint: Evaluation of pain intensity at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol. Method of measurement: Visual scale of pain.;Size of erosive and atrophic areas of oral lichen planus. Timepoint: Evaluation of pain intensity at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol. Method of measurement: Thongprasom index.

Secondary Outcome Measures

Name	Time	Method
ife quality. Timepoint: Evaluation of life quality at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol. Method of measurement: Questionnaire of chronic oral mucosal diseases.