Once-Daily Clobetasol Gel Matches Twice-Daily Dosing for Oral Lichen Planus, Swedish Trial Finds

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Posted: May 20, 2026

Once-Daily Clobetasol Gel Matches Twice-Daily Dosing for Oral Lichen Planus, Swedish Trial Finds

Edited by Dentaltown staff

A double-blind, randomized placebo-controlled trial published May 20 in BMC Oral Health found that topical clobetasol propionate 0.025% oral gel applied once daily was as effective as twice-daily dosing in reducing symptom severity in patients with symptomatic oral lichen planus, while both active regimens significantly outperformed placebo.

The multicenter trial, led by researchers at Malmö University in Sweden, enrolled 73 patients with symptomatic OLP and randomly assigned them to three groups: clobetasol propionate 0.025% oral gel twice daily, clobetasol once daily paired with placebo gel once daily, or placebo twice daily. All participants rinsed for one minute twice daily over four weeks and received nystatin antifungal prophylaxis.

The primary outcome was the Oral Disease Severity Score. Secondary outcomes included visual analogue scale scores for pain and burning sensation, the Oral Health Impact Profile-14, and the Global Rating of Change. Both active treatment groups showed statistically significant improvement in ODSS and GRC compared with placebo (p<0.05), with no significant difference between once-daily and twice-daily dosing. Pain, burning sensation, and OHIP-14 scores did not differ significantly across groups.

Adverse events were mild and not significantly different between intervention and placebo arms. However, 27% of participants developed oral candidiasis by the end of treatment despite receiving antifungal prophylaxis, a finding the authors flagged as clinically relevant for management.

The research team, led by Fredrik Gränse of the Faculty of Odontology at Malmö University, conducted the trial across the Department of Oral and Maxillofacial Surgery and Oral Medicine at Malmö University and the Department of Oral and Maxillofacial Surgery at Skåne University Hospital in Lund. Funding came from Region Skåne, the Swedish Association of Orofacial Medicine, and Sydsvenska Tandläkare-Sällskapet. The authors reported no competing interests.

The trial was registered at ClinicalTrials.gov under NCT04364555 and at the European Union Drug Regulating Authorities Clinical Trials database. The paper is currently available as an early-access unedited manuscript pending final copyediting.

Sources:
BMC Oral Health, “Topical clobetasol propionate 0.025% oral gel in the treatment of oral lichen planus: a double-blind, randomized placebo-controlled trial,” Gränse F, et al., May 20, 2026: link.springer.com/article/10.1186/s12903-026-08599-7
ClinicalTrials.gov, NCT04364555: clinicaltrials.gov/study/NCT04364555
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