Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial

Madsen, Lars Siim; Saunders, Deborah; Napeñas, Joel J.; McCreary, Christine; Ríordáin, Rícheal Ní; Pedersen, Anne Marie Lynge; Fedele, Stefano; Cook, Richard; Abdelsayed, Rafik; Llopiz, Maria T; Sankar, Vidya; Ryan, Kevin M.; Culton, Donna A.; Akhlef, Yousra; Castillo, Fausto; Fernandez, Inti; Jurge, Sabine; Kerr, Alexander Ross; McDuffie, Chad M.; McGaw, Tim; Mighell, Alan J.; Sollecito, Thomas P.; Schlieve, Thomas; Carrozzo, Marco; Papas, Athena; Bengtsson, Thomas; Al‐Hashimi, Ibtisam; Burke, Laurie B.; Burkhart, Nancy W.; Culshaw, Shauna; Desai, Bhavik; Hansen, Jens; Jensen, Peter Bo; Menné, Torkil; Patel, Paras; Treister, Nathaniel S.; Ruzicka, Thomas

doi:10.1111/jop.13270

Cited by 29 publications

(50 citation statements)

References 23 publications

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“…In addition, triamcinolone, betamethasone, fluocinonide, fluticasone, dexamethasone, and prednisolone in different topical forms, such as ointment, oral suspension, aqueous solution, mouthwash, and adhesive paste, have been proven to be effective and safe ( 5 ). In a recent phase II RCT, a novel mucoadhesive clobetasol patch (Rivelin ® -CLO) was tested on patients with erosive OLP ( 44 ). An improvement in OLP symptoms was reported in the verum group (25/32) compared to the placebo group (11/30), ( p = 0.012) ( 44 ).…”

Section: Corticosteroidsmentioning

confidence: 99%

“…In a recent phase II RCT, a novel mucoadhesive clobetasol patch (Rivelin ® -CLO) was tested on patients with erosive OLP ( 44 ). An improvement in OLP symptoms was reported in the verum group (25/32) compared to the placebo group (11/30), ( p = 0.012) ( 44 ). The authors concluded that Rivelin ® -CLO patches were superior to placebo, demonstrating statistically significant objective and subjective improvement and a favorable safety profile ( 44 ).…”

Section: Corticosteroidsmentioning

confidence: 99%

“…The authors concluded that Rivelin ® -CLO patches were superior to placebo, demonstrating statistically significant objective and subjective improvement and a favorable safety profile ( 44 ). Intralesional injection of CS, such as triamcinolone acetonide, hydrocortisone, dexamethasone, and methylprednisolone, are effective in erosive OLP, but this approach is extreme painful for the patient and only a few erosions can be treated in each session ( 44 , 45 ).…”

Section: Corticosteroidsmentioning

confidence: 99%

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Therapeutic strategies for oral lichen planus: State of the art and new insights

et al. 2022

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Oral lichen planus (OLP) is a chronic inflammatory disease of the oral mucosa. Several clinical subtypes of OLP have been reported, including the reticular and erosive one. On the one hand, reticular OLP is usually asymptomatic and is characterized by white streaks surrounded by well-defined erythematous borders. On the other hand, erosive OLP shows ulcerations and erosions surrounded by erythematous mucosa. While reticular OLP is relatively easy to control, erosive OLP is extremely painful and refractory to therapies, limiting the quality of life of the patients. In addition, treating erosive OLP is extremely tricky, and a gold standard treatment has not yet been established. However, several therapeutic approaches have been reported as effective, including systemic corticosteroids, systemic retinoids, and anti-interleukin (IL)-17/anti-IL-23 drugs. Indeed, our group and other several authors reported the effectiveness of anti-IL17, anti-IL12/23, and anti-IL23 agents in refractory OLP, highlighting the urgency of clinical studies on the use of anti-IL agents in OLP patients. In this paper, we reviewed the English- and German-language literature about therapeutic strategies for treating OLP, focusing on new systemic therapies for erosive OLP.

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Section: Corticosteroidsmentioning

confidence: 99%

Section: Corticosteroidsmentioning

confidence: 99%

Section: Corticosteroidsmentioning

confidence: 99%

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Therapeutic strategies for oral lichen planus: State of the art and new insights

et al. 2022

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“…Patients treated with Rivelin-CLO showed a significant reduction in ulcer size compared to placebo. The data showed that 20 μg Rivelin-CLO patch treatment demonstrated significant improvements in ulcer size ( p = 0.047), symptom severity ( p = 0.001), disease activity ( p = 0.022), pain ( p = 0.012) and quality of life ( p = 0.003) [ 135 ]. Currently, most oral electrostatic spun patches are in the research phase.…”

Section: Electrospinning In the Treatment Of Oral Ulcersmentioning

confidence: 99%

Advances in the Application of Electrospun Drug-Loaded Nanofibers in the Treatment of Oral Ulcers

et al. 2022

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Oral ulcers affect oral and systemic health and have high prevalence in the population. There are significant individual differences in the etiology and extent of the disease among patients. In the treatment of oral ulcers, nanofiber films can control the drug-release rate and enable long-term local administration. Compared to other drug-delivery methods, nanofiber films avoid the disadvantages of frequent administration and certain side effects. Electrospinning is a simple and effective method for preparing nanofiber films. Currently, electrospinning technology has made significant breakthroughs in energy-saving and large-scale production. This paper summarizes the polymers that enable oral mucosal adhesion and the active pharmaceutical ingredients used for oral ulcers. Moreover, the therapeutic effects of currently available electrospun nanofiber films on oral ulcers in animal experiments and clinical trials are investigated. In addition, solvent casting and cross-linking methods can be used in conjunction with electrospinning techniques. Based on the literature, more administration systems with different polymers and loading components can be inspired. These administration systems are expected to have synergistic effects and achieve better therapeutic effects. This not only provides new possibilities for drug-loaded nanofibers but also brings new hope for the treatment of oral ulcers.

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“…Due to the presence of this chronic inflammation, meticulous plaque removal does not usually result in complete resolution of DG [14,23], and other specific treatments, such as topical corticosteroids are needed to reduce the DG lesions and their associated signs and symptoms [24][25][26][27]. Other anti-inflammatory and immunosuppressant treatments such as systemic steroids, topical tacrolimus, topical pimecrolimus, mycophenolate, methotrexate, dapsone, and retinoic acid have also been used in refractory cases or in presence of extensive lesions of DG [28].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of a bioadhesive gel containing propolis extract, nanovitamin C and nanovitamin E on desquamative gingivitis: a double-blind, randomized, clinical trial

et al. 2022

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Objectives To evaluate the efficacy of a gel-containing propolis extract, nanovitamin C, and nanovitamin E as adjuvants to professional plaque removal on desquamative gingivitis (DG). Materials and methods A randomized clinical trial was conducted on patients suffering DG due to mucocutaneous diseases. Patients received professional supragingival prophylaxis with oral hygiene instructions and were randomly assigned to use test or control gels as toothpaste and to apply it on DG lesions 3 times/day for 4 weeks. DG clinical score (DGCS), clinical periodontal variables, and visual analog scale (VAS) for pain and oral health impact profile (OHIP-14) were collected at baseline, 2 and 4 weeks. Results Twenty-two patients were randomly assigned to test (n = 11) or control group (n = 11). Eighteen had diagnosis of oral lichen planus and four of mucous membrane pemphigoid. DGCS statistically decreased in both groups after treatment with no significant differences between groups. Clinical periodontal outcomes decreased in both groups, but no significant differences were observed. Periodontal variables statistically improved only in test group after treatment. VAS and OHIP-14 scores decreased in test and control groups without significant differences. However, only one test group showed a statistically significant decrease in VAS and OHIP-14 scores after treatment. No adverse effects were reported. Conclusions Test gel may alleviate DG and improve quality of life without side effects. Clinical relevance A gel-containing propolis extract, nanovitamin C, and nanovitamin E as adjuvants to mechanical debridement may improve both clinical and patient related outcomes in DG patients without side effects. Clinical trial registration. The study protocol was registered at clinicaltrials.gov with the following number: NCT05124366 on October 16, 2021.

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Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial

Cited by 29 publications

References 23 publications

Therapeutic strategies for oral lichen planus: State of the art and new insights

Therapeutic strategies for oral lichen planus: State of the art and new insights

Advances in the Application of Electrospun Drug-Loaded Nanofibers in the Treatment of Oral Ulcers

Efficacy and safety of a bioadhesive gel containing propolis extract, nanovitamin C and nanovitamin E on desquamative gingivitis: a double-blind, randomized, clinical trial

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