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Background <p>Oral lichen planus (OLP) is a chronic immune‑mediated inflammatory disorder affecting the oral mucosa and characterized by recurring exacerbations and remissions. Complete healing is uncommon. Currently, there is no established curative therapy for OLP. Management strategies are aimed at alleviating clinical symptoms by reducing the underlying inflammatory response. Although some effect of topical corticosteroids has been reported, the level of evidence remains low, as few studies are randomized and placebo controlled. This study evaluated the efficacy of clobetasol compared with placebo in the treatment of symptomatic OLP and sought to determine whether once-daily is as effective as twice-daily administration.</p> Methods <p>Patients with symptomatic OLP were randomly allocated to three treatment groups: clobetasol propionate 0.025% oral gel twice daily (Active 2, <i>n</i> = 22), clobetasol propionate 0.025% oral gel once daily and placebo oral gel once daily (Active 1, <i>n</i> = 26) and placebo oral gel twice daily (Placebo, <i>n</i> = 25). All three groups were instructed to rinse with the assigned oral gel for 1&#xa0;min twice daily for 4 weeks. The primary outcome was the Oral Disease Severity Score (ODSS). Secondary outcomes were the visual analogue scale (VAS) score for pain, the VAS score for burning sensation, the Oral Health Impact Profile (OHIP-14), and the Global Rating of Change (GRC).</p> Results <p>In both intervention groups (Active 2 and 1), improvement in the ODSS (<i>p</i> &lt; 0.05) and the GRC (<i>p</i> &lt; 0.05) after 4 weeks was significant compared with control group (Placebo). No significant differences were observed between the intervention groups in ODSS and GRC. Nor were any significant differences in the pain score, the burning sensation score, or the OHIP-14 noted between the intervention groups and the control group. Adverse events were mild with no significant differences between the intervention groups and the control group. Despite receiving antifungal prophylaxis, 27% of the participants had oral candidiasis at the end of treatment.</p> Conclusions <p>The results suggest that topical clobetasol propionate 0.025% oral gel is more effective than placebo in improving disease severity (ODSS) and global change (GRC) in patients with symptomatic OLP. The results also suggest that once-daily treatment is as effective as twice-daily treatment.</p> Trial registration <p>This trial was registered at Clinical Trials.gov on April 20, 2020, under registration number NCT04364555.</p>

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Topical clobetasol propionate 0.025% oral gel in the treatment of oral lichen planus: a double-blind, randomized placebo-controlled trial

  • 期刊论文

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  • 发表日期：

    2026年5月20日

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  • Fredrik Gränse,
  • Liv Kroona,
  • Anna Truedsson,
  • Cecilia Larsson Wexell,
  • Bengt Götrick

摘要

Background

Oral lichen planus (OLP) is a chronic immune‑mediated inflammatory disorder affecting the oral mucosa and characterized by recurring exacerbations and remissions. Complete healing is uncommon. Currently, there is no established curative therapy for OLP. Management strategies are aimed at alleviating clinical symptoms by reducing the underlying inflammatory response. Although some effect of topical corticosteroids has been reported, the level of evidence remains low, as few studies are randomized and placebo controlled. This study evaluated the efficacy of clobetasol compared with placebo in the treatment of symptomatic OLP and sought to determine whether once-daily is as effective as twice-daily administration.

Methods

Patients with symptomatic OLP were randomly allocated to three treatment groups: clobetasol propionate 0.025% oral gel twice daily (Active 2, n = 22), clobetasol propionate 0.025% oral gel once daily and placebo oral gel once daily (Active 1, n = 26) and placebo oral gel twice daily (Placebo, n = 25). All three groups were instructed to rinse with the assigned oral gel for 1 min twice daily for 4 weeks. The primary outcome was the Oral Disease Severity Score (ODSS). Secondary outcomes were the visual analogue scale (VAS) score for pain, the VAS score for burning sensation, the Oral Health Impact Profile (OHIP-14), and the Global Rating of Change (GRC).

Results

In both intervention groups (Active 2 and 1), improvement in the ODSS (p < 0.05) and the GRC (p < 0.05) after 4 weeks was significant compared with control group (Placebo). No significant differences were observed between the intervention groups in ODSS and GRC. Nor were any significant differences in the pain score, the burning sensation score, or the OHIP-14 noted between the intervention groups and the control group. Adverse events were mild with no significant differences between the intervention groups and the control group. Despite receiving antifungal prophylaxis, 27% of the participants had oral candidiasis at the end of treatment.

Conclusions

The results suggest that topical clobetasol propionate 0.025% oral gel is more effective than placebo in improving disease severity (ODSS) and global change (GRC) in patients with symptomatic OLP. The results also suggest that once-daily treatment is as effective as twice-daily treatment.

Trial registration

This trial was registered at Clinical Trials.gov on April 20, 2020, under registration number NCT04364555.