COLE Study

JRCT ID: jRCTs051220130

Registered date:09/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral lichen planus
• Date of first enrollment: 16/12/2022
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Group A : cepharanthin administration group
Patients will be given cepharanthin 30mg per day and administered orally in divided dose after each meal for 8 weeks. They will apply topical dexamethasone 0.1% ointment on the dried lesion 3 times a day.
Group B :cepharanthin non-administration group
Patients will apply dexamethasone 0.1% ointment on the dried lesion 3 times a day.

Outcome(s)

• Primary Outcome: The change of pain intensity when drinking room temperature water from baseline to week 8 according to a Visual analog scale (VAS) ratings (0-100 mm: 0 = no pain, 100 = worst possible pain).

Secondary Outcome

1. The change of the main diameter of the worst lesion from baseline to 4 and 8 weeks after enrollment
2. The improvement and deterioration rates based on the severity classification by Saki et al. 4 and 8 weeks after enrollment
3. The improvement and deterioration rates based on the criteria scale of Thongprasom et al. 4 and 8 weeks after enrollment
4. The change of pain intensity when drinking room temperature water from baseline to 4 weeks after enrollment according to VAS
5. The change of pain intensity at rest from baseline to 4 weeks after enrollment according to VAS
6. Safery Evaluation
Incidences of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)20 years old or over
2)Patients with oral lichen planus diagnosed clinically and histopathologically,
3)Patients with oral lichen planus with moderate or higher (Grade 2 or 3) pain in the severity classification of CTCAE v5.0
4)Patients with ECOG Performance Status (PS) of 0-3
5)Patients providing the written informed consent

Exclude criteria

1. Patients with previous treatment of cepharanthin
2. Patients with a history of radiotherapy in the oral cavity
3. Patients receiving or having a plan to receive systemic administration of anticancer drugs, immunosuppressants and analgesic drugs.
4. Patients with a history of hypersensitivity to dexamethasone oral ointment
5. Pregnant women and women suspected of being pregnant
6. Lactating women
7. Patients with severe liver disfunction (AST, ALT and GTP >= 5.0 times the upper limit of the standard value, T-Bil >= 3.0 times the upper limit of the institutional standard value)
8. Patients who are unlikely to provide effective informed consent
9. Any other patients who are regarded as unsuitable for this study by the investigators.

Related Information

• Primary Sponsor: Yagyuu Takahiro
• Source(s) of Monetary Support: Medisa Shinyaku Inc.,Nara Medical University