Efficacy and safety of thalidomide on erosive oral lichen planus

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078677

Enrollment

Unknown

Registered

2023-12-14

Start date

2023-12-14

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Oral lichen planus

Interventions

Group A:Thalidomide Tablets

Group B:Prednisone Acetate Tablets

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) age between 18 to 65 years old; (2) patients with clinical or pathological diagnosis of erosive oral lichen planus; (3) single erosion area = 1 square centimeter, or the total area of ??multiple erosions = 1 square centimeter, Or the erosion area is less than 1 square centimeter with the total area of ??surrounding atrophic lesions is =1 square centimeter; (4) the total disease duration exceeds 2 months; (5) postmenopausal women; men who agree to use birth control measures with their sex partners to avoid pregnancy during treatment and within 3 months after treatment; (6) normal blood pressure, pulse, respiration and body temperature; (7) ) normal physical examination before intervention; (8) normal superficial sensation(touch, pain, two-point discrimination) and deep sensation(position sense); (9) participate voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) men who plan to have a baby within 4 months; (2) presence of severe systemic disease that can not control by medicine; (3) patients who suffer from peripheral neuropathy; (4)patients who have peptic ulcer;(5) history of allergies to thalidomide or prednisone; (6) those took immunotherapy during the previous 1 months; or had topical treatment within a week prior to enrollment in this study; (7)presence of lichenoid lesions (caused by amalgam fillings or certain medications); (8) extraoral lesions of lichen planus;(9)patients with other serious oral mucosal diseases (such as pemphigus, chronic discoid lupus erythematosus, etc.);(10)patients who refuse to follow the doctor's advice or to complete the follow-up review.

Design outcomes

Primary

Measure	Time frame
erosive lesion size;pain level;	—

Secondary

Measure	Time frame
reticular lesion size;atrophic lesion size;Thongprasom score;healing rate;recurrence rate;	—

Countries

China

Contacts

Public ContactHongmei Zhou

West China College of Stomatology, Sichuan University

acomnet@126.com+86 28 8550 3480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026