Researchers have completed a pilot study that shows promise for patients with oral lichen planus (OLP), which can result in a burning sensation, pain, and ulcers in the mouth, according to PCCA, a chemical repackager and relabeler in Houston, Texas.
Results of the study show that a compounded steroid solution that included a patent-pending drug-delivery technology manufactured by PCCA called MucoLox was clinically well tolerated and more effective for patients with OLP than a commonly used solution of the same steroid.
A chronic inflammatory condition caused by the body’s immune system attacking tissues in the mouth, OLP occurs in 1% to 2% of adults, PCCA said.
The study tested the tolerability and effectiveness of a compounded oral steroid solution compared to a standard solution in a group of 20 adults diagnosed with OLP. The subjects swished the solutions in their mouths for five minutes and spit them out three times a day for four weeks.
Twelve of the adults used a commonly prescribed liquid with dexamethasone, a corticosteroid that can help reduce inflammation. The other eight adults used a liquid with dexamethasone and MucoLox, a gel that adheres to mucous membranes (mucoadhesion) and is used to make customized medications for patients with certain oral conditions.
The researchers hypothesized that the solution with MucoLox would be well tolerated and lead to better outcomes because it would adhere to oral tissue and increase the contact time between the medication and the tissue. The study resulted in better objective and subjective outcomes with the MucoLox, the researchers said.
“One of the factors determining how well a medication works is whether it can get to a desired site of action in the body and exert a beneficial effect,” said Gus Bassani, PharmD, study author and chief scientific officer at PCCA.
“If we can improve medication delivery to that site and prolong its effects, we may be able to improve outcomes. It is exciting to see the improved clinical response in this preliminary study resulting from the use of the MucoLox delivery system,” said Bassani.
The researchers acknowledged some limitations in their study, including the use of a small cohort of patients, and noted that larger studies are needed to confirm their findings. However, the said that the study does provide preliminary data on a promising drug-delivery option for patients with OLP.
The study, “Dexamethasone Solution and Dexamethasone in Mucolox for the Treatment of Oral Lichen Planus: A Preliminary Study,” was published by Oral Surgery, Oral Medicine, Oral Pathology, and Oral Radiology.
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