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- W2800373669 abstract "OLP is an inflammatory oral diseasen where erosive painful lesions impact quality of life. Todays treatments applying steroids as mouthwashes, creams or ointments are often ineffective due to inadequate drug exposure. The Rivelin® patch is a two-layer bio-adhesive patch. The inner drug containing layer adheres to moist surfaces and the outer layer protects from mechanical stress. Preclinical data indicate that a clobetasol containing Rivelin® patch has the potential to overcome the current treatment challenges fulfilling an unmet need. Objectives: 1) Investigate adhesion time and tolerability of Rivelin plain patches applied to symptomatic OLP lesions. 2) Evaluate the feasibility to apply patches. Methods: A total of 13 symptomatic OLP were enrolled in an open label study, to confirm the tolerability and safety profile of plain patches in patients. Out of 13 OLP patients did 12 complete the study. A target lesion was identified by the investigator and subjects applied 1-2 patches to the target lesion twice daily for 28 days. Patients were assessed at weekly visits and data on adhesion time and symptoms were collected in daily diaries. Results: Mean adhesion time was ∼ 90 mins. An assessment of the tolerability and sensation of the Rivelin plain patches revealed a profound positive feedback. No worsening of symptoms and lesions were observed. All subjects could succesfully apply patches. Conclusions: The Rivelin® patch provide a new treatment strategy. Based on these findings the Clo patch will be evaluated in a phase 2b study in 240 symptomatic OLP patients with the assumption of providing longer contact time of Clobetasol at lesion site, securing a unidirectional fixed dose (two-layer patch) and a high compliance (all patients could apply patches with a favorable tolerability and sensation profile)." @default.
- W2800373669 created "2018-05-17" @default.
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- W2800373669 date "2018-05-01" @default.
- W2800373669 modified "2023-09-26" @default.
- W2800373669 title "535 The Rivelin® patch an adhesive patch for targeted treatment of oral lichen planus" @default.
- W2800373669 doi "https://doi.org/10.1016/j.jid.2018.03.543" @default.
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