Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial

Int J Environ Res Public Health. 2020 Dec 23;18(1):56. doi: 10.3390/ijerph18010056.


Oral lichen planus (OLP) is a chronic, inflammatory, immune-mediated disease, which can alter the quality of life of patients. The aim of this randomized clinical trial was to compare the therapeutic efficacy of clobetasol oral gel 0.05% versus an anti-inflammatory in oral solution (mouthwash) in the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects. Forty patients were assigned (20 patients for group), through a randomized design, to receive clobetasol gel 0.05% or an anti-inflammatory mouthwash, which contains calcium hydroxide, hyaluronic acid, umbelliferone and oligomeric pro-anthocyanidins) for three months. At baseline (T0) and after 3 months (T1), patients underwent dental and dermatological examinations to assess their symptoms (Numerical Pain Scale (NRS) score) and signs (Thongprasom score). Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Whitney u test. Both clobetasol and anti-inflammatory resulted in a statistically significant reduction of signs, (p < 0.001 and p = 0.02, respectively) and symptoms (p < 0.001 for clobetasol and p = 0.02 for anti-inflammatory). In conclusion, the results evidenced that, compared to clobetasol, the anti-inflammatory was less effective in determining the reduction of signs and symptom in OLP patients.

Trial registration: NCT04673916.

Keywords: Thongprasom’s Score; calcium hydroxide; clobetasol; hyaluronic acid; oligomeric pro-anthocyanidins; oral lichen planus; oral solution; therapy; umbelliferone.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Aged
  • Anti-Inflammatory Agents / therapeutic use
  • Clinical Protocols
  • Clobetasol / therapeutic use
  • Double-Blind Method
  • Female
  • Humans
  • Lichen Planus, Oral* / drug therapy
  • Male
  • Middle Aged
  • Mouthwashes / therapeutic use*
  • Quality of Life


  • Anti-Inflammatory Agents
  • Mouthwashes
  • Clobetasol

Associated data