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

Phase 4

Conditions: oral lichen planus

Registration Number: SLCTR/2022/012

Lead Sponsor: Department of Pharmacology, Faculty of Medicine, University of Peradeniya

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.]<br>Adverse events measured using an interviewer administered questionnaire and,<br>haematological toxicity<br>Full blood count – abnormality in blood counts such as pancytopenia, bicytopenia or isolated reductions in any cell line will be taken as hematological abnormality.<br>Liver toxicity<br>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.]<br> []<br> []<br> []<br>

Secondary Outcome Measures