US-based biopharmaceutical company Biofrontera has finished enrolling subjects in its multicentre Phase III trial of Ameluz (aminolevulinic acid hydrochloride) topical gel 10% for treating mild-to-moderate actinic keratoses (AKs).
The randomised, double-blind trial is comparing Ameluz with a vehicle gel in treating AK on the extremities, neck and trunk, using the RhodoLED lamp photodynamic therapy (PDT).
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It has been designed to evaluate Ameluz’s efficacy and safety as a PDT after the application of one to three tubes of the product on surface areas of nearly 80cm², 160cm² or 240cm².
Subjects who still have at least one lesion after receiving either Ameluz or vehicle gel will be given a second treatment after 12 weeks before being followed up for around a year thereafter.
A total of 172 subjects have been enrolled in the trial, with treatments administered in a 4:1 ratio of Ameluz to vehicle gel.
AKs are widespread pre-cancerous skin lesions caused by chronic exposure to the sun. They can potentially evolve into squamous cell carcinoma if left untreated.
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By GlobalDataBiofrontera chairman and CEO Dr Hermann Luebbert said: “We are thrilled to reach this pivotal stage in our clinical programme.
“The successful enrolment of our last patient brings us one step closer to potentially offering an effective treatment option for patients with actinic keratoses on the extremities, neck and trunk.
“It marks a significant step in expanding the indications for Ameluz and further demonstrates our commitment to the development of PDT.”
Biofrontera expects the trial’s treatment phase to be completed by September this year while the follow-up phase is expected to conclude by the second quarter of next year.
Positive outcomes could lead to a supplemental new drug application (NDA) submission to the US Food and Drug Administration (FDA) in the second half of next year.
Based in Massachusetts, Biofrontera develops PDTs and other treatments for a range of dermatological conditions.
