COLE Study

Phase 2

Recruiting

• Conditions: Oral lichen planus

• Registration Number: JPRN-jRCTs051220130
• Lead Sponsor: Yagyuu Takahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion 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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

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