Efficacy of mometasone furoate microemulsion in the treatment of erosive-ulcerative oral lichen planus: pilot study.
BACKGROUND
Oral lichen planus (OLP) is a frequent immunological chronic disease, having different clinical forms: asymptomatic and symptomatic. Symptomatic OLP has been palliated with topical corticosteroids with different levels of efficacy and safety. The purpose of this pilot phase II clinical trial was to determine the efficacy of mometasone furoate microemulsion upon the symptoms and signs of erosive-ulcerative OLP.


METHODS
Forty-nine patients with clinical and histologically confirmed erosive-ulcerative OLP were enrolled in this study (36 women and 13 men). Their average age was 56.4 years (from 28 to 78). The treatment consisted of 0.1% mometasone furoate microemulsion mouthwash three times a day over 30 days. Pain, erythema and ulceration were assessed after 15 and 30 days of treatment. The data was processed and statistically analysed by student's t-test for paired samples.


RESULTS
Mometasone caused a statistically significant reduction in pain (3.58 vs. 0.65, P = 0.0000). Treatment significantly reduced the surface area of erythema (155.2 vs. 21.9 mm(2), P = 0.0001) and ulceration (30.7 vs. 7.3 mm(2), P = 0.0000). None of these patients suffered severe adverse effects.


CONCLUSIONS
Mometasone furoate microemulsion is a safe and effective therapy in the treatment of symptomatic erosive-ulcerative OLP.
Aguirre
J M
JM
Medicina y Patología Bucal, Medicina Preventiva y Salud Pública, Facultad de Medicina y Odontología, Universidad del País Vasco/EHU, Spain. otpagurj@lg.ehu.es
Bagán
J V
JV
Rodriguez
C
C
Jimenez
Y
Y
Martínez-Conde
R
R
Díaz de Rojas
F
F
Ponte
A
A
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004655:Emulsions; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D017676:Lichen Planus, Oral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D009067:Mouthwashes / Q000627:therapeutic use*; D010865:Pilot Projects; D011244:Pregnadienediols / Q000008:administration & dosage / Q000627:therapeutic use*
D000893:Anti-Inflammatory Agents; D004655:Emulsions; D005938:Glucocorticoids; D009067:Mouthwashes; D011244:Pregnadienediols; D000068656:Mometasone Furoate