Efficacy and safety study ofglycyrrhetinic acid / CMC-Na ointment for oral lichen planus

JRCT ID: jRCTs031220306

Registered date:31/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral lichen planus
• Date of first enrollment: 08/08/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Topical treatment with glycyrrhetinic acid and CMC-Na ointment

Outcome(s)

Primary Outcome

Safety (clinical endpoints considered as adverse effects)
Collect adverse events that have occurred.
Detect abnormal values in laboratory tests.

Secondary Outcome

The efficacy rate will be calculated by comparing the numerical values of each endpoint before and after admi nistration of the study drug.

The lesions are observed with an intraoral fluorescent observation device.

The ROI (Region On Interest) of the lesion is defined as the area including the dark area and the area of reduced fluorescence visibility, and the ROI area (pixels), mean and standard deviation of luminance (cd/m2 ), coefficient of variation (standard deviation/mean luminance) and luminance ratio ((lesion/control) x 100%] is calculated.

Thongprasom score
0: No findings, normal mucosa
1: No erosive mucosal findings, although there is a mild white linear zone
2: White linear zone is present and the area of mucosal atrophy is less than 1 cm2.
3: White linear bands are present and the area of mucosal atrophy is larger than 1 cm2.
4: White linear bands are present and the area of erosion of the mucosa is less than 1 cm2.
5: White linear bands are present and the mucosal erosions are more extensive than 1 cm2.

Immunohistological staining is performed on biopsy specimens to diagnose oral lichen planus. Staining of these markers
(protein expression status) are classified as negative (0-4%), weak (5-25%), moderate (26-50%), strong
(51-100%). The expression status of each and the effect of this treatment will be reviewed retrospectively.
Bax (apoptosis-promoting marker)
BCL-2 (anti-apoptotic marker)
CD-138 (cell adhesion marker)
Histone 3 (cell proliferation marker)
MCM 3 (cell proliferation marker)
p53 (tumor suppressor marker)
CD8 (T cell marker)

NRS evaluation of blotchy symptoms and pain.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with first-episode oral lichen planus whose pathological diagnosis of oral lichen planus was confirmed by biopsy
2) Steroid-naive patients with oral lichen planus or patients with a history of steroid treatment but more than one month since last use
3) Patients with complaints of pain due to oral lichen planus (Numerical Rating Scale; NRS 1 or more)
4) Patients who are at least 18 years of age at the time of consent
5) Patients who have been fully informed, understand, and give written consent to participate in this study
6) Outpatients

Exclude criteria

1) Patients with severe pain due to oral lichen planus (mean NRS 7 or more)
2)Patients with hypersensitivity to the study drug
3) Pregnant patients
4) Patients with active malignancy
5) Patients who are using or will use biologic agents during the study period
6) Patients who are using or will use immunosuppressive drugs during this study
7) Patients receiving steroid therapy for diseases other than lichen planus of the oral cavity
8) Patients with suspected acute abdomen
9) Patients with severe hard stools

Related Information

• Primary Sponsor: Uchida Fumihiko
• Source(s) of Monetary Support: University of Tsukuba Hospital