Effects of two mucoadhesive forms of Clobetasol on oral lichen planus

Laboratory Indexes and Therapeutic Effects of Two Mucoadhesive Systems Containing Clobetasol on Oral Lichen Planus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200425047195N1

Enrollment

Registered

2020-12-07

Start date

2020-09-26

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral lichen planus. Lichen planus

Interventions

Intervention 1: Intervention group: 1. Consumables specifications: mucoadhesive gel clobetasol RDN 0.05%. Chemical composition and concentration: each 100 mg contains 50 mg Clobetasol Propionate. Drug

Eligibility

Sex/Gender

All

Age

16 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Life 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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh Khozeimeh

Esfahan University of Medical Sciences

Khozeimeh@dnt.mui.ac.ir+98 31 3267 5638

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026