Comparison of the effectiveness and safety of hydroxychloroquine and methotrexate added to standard treatment (systemic steroids) versus standard treatment alone in the treatment of moderate to severe oral lichen planus

Comparison of the effectiveness and safety of hydroxychloroquine and methotrexate in the treatment of moderate to severe oral lichen planus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2022/012

Enrollment

Unknown

Registered

2022-05-20

Start date

2022-07-10

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

oral lichen planus

Interventions

Study setting: The study will be conducted at the Oral Medicine Clinic, Faculty of Dental Sciences, University of Peradeniya. Intervention: This is a three armed clinical trial, intended to compare e

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-60 years, both male and female. 2. Patients with histologically confirmed moderate to severe OLP with or without skin involvement (a pain score of 6 or greater on a VAS of 0 to 10) 3. Histological confirmation of diagnosis from an incisional biopsy from oral mucosa 4. Sinhala / English speaking patients

Exclusion criteria

Exclusion criteria: 1. Patients with psychiatric disorders 2. Pregnant or lactating women (to exclude pregnancy in premenopausal women, treatment will be commenced after the next menstrual period or if still unsure, after a negative urine hCG test.) 3. Patients with contraindications for HCQ or MTX 4. Patients with poorly controlled diabetes 5. Patients with known retinal diseases 6. Patients with other dermatological conditions in addition to LP 7. Patients who have received treatment for LP previously 8. Patients with contraindications to long-term steroids

Design outcomes

Primary

Measure	Time frame
Severity of oral lesions as assessed using a questionnaire including the Guy’s Oral Disease Severity Scoring system (Guy’s ODSS), VAS scale, Lichen Planus Severity Index and photographs. [Every fortnight for a total duration of 16 weeks.] Adverse events measured using an interviewer administered questionnaire and, haematological toxicity Full blood count – abnormality in blood counts such as pancytopenia, bicytopenia or isolated reductions in any cell line will be taken as hematological abnormality. Liver toxicity Alternation in SGOT/SGPT such as three times the normal level will be taken as hepatic injury [ Every fortnight for a total duration of 16 weeks.] [] [] []	—

Measure

Time frame

Severity of oral lesions as assessed using a questionnaire including the Guy’s Oral Disease Severity Scoring system (Guy’s ODSS), VAS scale, Lichen Planus Severity Index and photographs. [Every fortnight for a total duration of 16 weeks.] Adverse events measured using an interviewer administered questionnaire and, haematological toxicity Full blood count – abnormality in blood counts such as pancytopenia, bicytopenia or isolated reductions in any cell line will be taken as hematological abnormality. Liver toxicity Alternation in SGOT/SGPT such as three times the normal level will be taken as hepatic injury [ Every fortnight for a total duration of 16 weeks.] [] [] []

—

Secondary

Measure	Time frame
None []	—

Countries

Sri Lanka

Contacts

Public ContactSanjeewani Fonseka

Senior Lecturer

sanjeewani.fonseka@yahoo.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026