A new treatment for the papules and pustules of rosacea has been given its product name. Publicity surrounding the trial of the new benzoyl peroxide based rosacea topical has mentioned that the product is to be called Epsolay.
Previously Epsolay has been known as VERED, S5G4T-1 and DER 45 EV.
It is encouraging that Epsolay has reached the Phase-III study status. Time will tell how well rosacea sufferers tolerate and benefit from this formulation of benzoyl peroxide.
Sol-Gel doses first patient in Phase III trial of Epsolay
Sol-Gel Technologies has dosed the first patient in a pivotal Phase III clinical trial programme designed to analyse the safety and efficacy of Epsolay (formerly VERED) for the treatment of patients with papulopustular rosacea, also known as subtype II rosacea.
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It includes two randomised, multi-centre, double-blind, vehicle-controlled clinical trials, which are expected to enrol a total of 700 subjects at 50 sites in the US.
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The trials’ primary efficacy goals are success in Investigator Global Assessment (IGA), measured as a two-grade reduction in IGA on a scale of zero to four with ‘clear’ or ‘almost clear’ at week 12, and a decrease in mean inflammatory lesion count at week 12.
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“Epsolay is aimed to address the need for more effective treatments for inflammatory papules and pustules of rosacea, a chronic condition for which patients often have low adherence to current drugs.”
Epsolay is a once-daily topical cream that features encapsulated benzoyl peroxide, and has been developed using Sol-Gel’s proprietary microencapsulation technology.
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when might this product become available for purchase
It is encouraging that the trials are at stage 3, but it still can be months to years to complete and get approval. Also they will need to undertake a distribution deal with someone in order to get it into the hands of everyone. So, sadly, still some time way.
I was asked to participate in their trial last week but I live in Ct. and their trials were in Virginia I believe so too far to travel I was not allowed due to the fact I would have to report every two weeks or so to the physician running the trial. So the human trials are happening now, I was disappointed that I was not eligible but at least it’s happening. I signed up for some website that looks for people to participate in trial situations and sometimes it’s just too far to be a part of.
Rob