A randomized double-blind, positive-control trial of topical thalidomide in erosive oral lichen planus.
OBJECTIVE
The objective of this study was to evaluate the short-term efficacy and safety of topical thalidomide for erosive oral lichen planes (OLP) in a prospective randomized, positive-control, double-blind clinical trial.


METHODS
Sixty-nine patients with erosive OLP received thalidomide 1% paste (n = 37) or dexamethasone 0.043% paste (n = 32) for 1 week. Patients without erosions after initial 1-week treatment were followed for recurrence, whereas those with ongoing erosions received an additional 3-week treatment. Outcome measures included size of erosive area, visual analog scale (VAS) scores, 3-month recurrence rates, and adverse effects at 1 year.


RESULTS
After 1-week application, both groups showed significant reductions in erosive areas and VAS scores (P < .001). Complete healing occurred in 18 (54.5%) of 33 thalidomide-treated and 17 (56.7%) of 30 dexamethasone-treated patients. Erosive area size (P = .420) and VAS scores (P = .498) were similar between groups. After 1 month of treatment, 24 patients receiving thalidomide (66.7%) and 22 receiving dexamethasone (73.3%) fully healed. There was no difference between groups in recurrence at the 3-month follow-up. Only 2 patients in each group experienced discomfort with treatment, and no adverse reactions were observed over 1 year of follow-up.


CONCLUSIONS
Topical thalidomide appears as effective as dexamethasone for erosive OLP.
Wu
Yun
Y
State Key Laboratory of Oral Disease, West China College of Stomatology, Sichuan University, Chengdu, Sichuan and Wuhan, Hubei, China.
Zhou
Gang
G
Zeng
Hong
H
Xiong
Chun-rong
CR
Lin
Mei
M
Zhou
Hong-mei
HM
D000287:Administration, Topical; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D003907:Dexamethasone / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D017676:Lichen Planus, Oral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010147:Pain Measurement; D011446:Prospective Studies; D012449:Safety; D018709:Statistics, Nonparametric; D013792:Thalidomide / Q000008:administration & dosage*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D009824:Ointments; D013792:Thalidomide; D003907:Dexamethasone