Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Brennan Michael T, Madsen Lars Siim, Saunders Deborah P, Napenas Joel J, McCreary Christine, Ni Riordain Richeal, Pedersen Anne Marie Lynge, Fedele Stefano, Cook Richard J, Abdelsayed Rafik, Llopiz Maria T, Sankar Vidya, Ryan Kevin, Culton Donna A, Akhlef Yousra, Castillo Fausto, Fernandez Inti, Jurge Sabine, Kerr Alexander R, McDuffie Chad, McGaw Tim, Mighell Alan, Sollecito Thomas P, Schlieve Thomas, Carrozzo Marco, Papas Athena, Bengtsson Thomas, Al-Hashimi Ibtisam, Burke Laurie, Burkhart Nancy W, Culshaw Shauna, Desai Bhavik, Hansen Jens, Jensen Pia, Menné Torkil, Patel Paras B, Thornhill Martin, Treister Nathaniel, Ruzicka Thomas
Аннотация
METHODS: Patients with confirmed OLP and measurable symptomatic ulcer(s) participated in a randomized, double-blind, placebo-controlled, multicenter clinical trial testing a novel mucoadhesive clobetasol patch (Rivelin® -CLO) in OLP across Europe, Canada, and the United States. Patients were randomized to placebo (nonmedicated), 1, 5, 20 µg Clobetasol/patch, twice daily, for 4 weeks. The primary endpoint was change in total ulcer area compared to baseline. Secondary endpoints included improvement from baseline in pain, disease activity, and quality of life.
RESULTS: Data were analyzed and expressed as mean [SD]. One hundred thirty-eight patients were included in the study; 99 females and 39 males, mean age was 61.1 [11.6] years. Statistical analyses revealed that treatment with 20-μg Rivelin® -CLO patches demonstrated significant improvement with ulcer area (p = 0.047), symptom severity (p = 0.001), disease activity (p = 0.022), pain (p = 0.012), and quality of life (p = 0.003) as compared with placebo. Improvement in OLP symptoms from beginning to the end of the study was reported as very much better (best rating) in the 20-µg group (25/32) patients compared to the placebo group (11/30), (p = 0.012). Adverse events were mild/moderate. Candidiasis incidence was low (2%).
CONCLUSIONS: Rivelin® -CLO patches were superior to placebo demonstrating statistically significant, clinically relevant efficacy in objective and subjective improvement and, with a favorable safety profile.