Epsolay is on its way, will it stay?

epsolay

The benzoyl peroxide based Epsolay is one step closer to becoming a new treatment for the papules and pustules of rosacea. Based on an active ingredient of 5% bezoyl peroxide, and encapsulating inside silica, the new cream has continued to be tested and now Phase 3 results have been published.

So what do the Phase 3 results show, and what should we expect if and when Epsolay gets approved as a rosacea treatment? Read on for what you need to know.

What is Epsolay?

Epsolay is the product name of a 5% benzoyl peroxide cream that has been created by an Israeli pharmaceutical company called Sol-Gel. We have previously known Epsolay as the in-development names S5G4T-1, DER 45 EV and VERED.

How does Epsolay work?

Here is a description of the mode of operation of Epsolay. Bear in mind that this is the story of the creators of this new treatment, keen to see their creation result in a commercial product. The story centers around the slow migration of the active ingredient onto the skin and a slowing of the oxidation of the skin that is typically induced by benzoyl peroxide,

Benzoyl peroxide has not been approved by the FDA for the treatment of rosacea and may cause significant skin irritation in rosacea patients.

Epsolay is an innovative topical cream containing microencapsulated benzoyl peroxide, 5%, in development for the treatment of papulopustular rosacea.

Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica microcapsules to create a barrier between the medication and the skin.

The slow migration of medication from the microcapsules delivers treatment doses onto the skin, while the barrier reduces the ability of benzoyl peroxide to induce the strong oxidation process that can result in significant skin irritation, such as erythema, burning and stinging.

Silica is chemically inert, photochemically and physically stable, and is safely used in topical products.

If approved, Epsolay has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product.

Read more about the Sol-Gel technology at their web site – Our Drug Delivery

Will Epsolay work for me?

Well certainly Sol-Gel will gladly promote the idea that yes, based on Phase 3 data you might experience clearance of your papules and pustules as early as 2 weeks after starting treatment.

Press Release

Sol-Gel Announces Positive Top-Line Results from Epsolay® Phase 3 Program in Papulopustular Rosacea

NESS ZIONA, Israel, July 08, 2019 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) (“Sol-Gel” or the “Company”), today announced positive results from its Phase 3 program evaluating Epsolay microencapsulated benzoyl peroxide cream, 5%, made with the Company’s proprietary microencapsulation technology, for the treatment of papulopustular rosacea.

In two 12-week clinical studies, SGT 54-01 and SGT 54-02, Epsolay demonstrated statistically significant improvement in both co-primary endpoints of (1) the number of patients achieving “clear” or “almost clear” in the Investigator Global Assessment (IGA) and (2) absolute mean reduction from baseline in inflammatory lesion count. In an additional analysis,

Epsolay demonstrated rapid efficacy achieving statistically significant improvements on both co-primary endpoints compared with vehicle as early as Week 2. Epsolay demonstrated a favorable safety and tolerability profile similar to vehicle.

James J. Leyden, M.D., dermatologist and Emeritus Professor CE of Dermatology at the University of Pennsylvaniacommented on the results, “It’s exciting that Epsolay delivered outstanding and rapid efficacy with a microencapsulated benzoyl peroxide without irritating the sensitive skin of rosacea patients.

These findings are extremely positive and, if Epsolay is approved, it has the potential to represent a significant advance in the treatment of papulopustular rosacea.”

Safety and Tolerability

How about bad reactions, though – how likely will rosacea sufferers experience some kind of adverse event?

The trial has shown that some of the participants experienced pain and also some participants had to discontinue the trial.

The real test for Epsolay will be whether it is as effective and less irritating for rosacea sufferers compared to a regular 5% benzoyl peroxide acne cream.

Epsolay appeared to be generally safe and well-tolerated with a low rate of cutaneous side effects (e.g., dryness, scaling, itching and burning/stinging) comparable to vehicle.

Adverse events were primarily mild to moderate in severity with the most frequently reported adverse events across both studies being application site erythema and application site pain reported by less than 3.4% of subjects.

There was no treatment-related serious adverse events, with a combined total of 2 unrelated serious adverse events (1 Epsolay, 1 vehicle) reported across both trials. A combined total of 11 subjects (9 Epsolay, 2 vehicle) discontinued treatment due to an adverse event across both trials.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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6 Reader Comments

  1. Mary Martin says:

    How will this be different from Soolantra?

  2. Karen Reznek says:

    I’ve been using an inexpensive, generic (no irritating perfumes or fillers) 5% benzoyl peroxide for a couple of years now. I built up my use gradually – a thin layer every 3 days, every 2 days, then once a day. At that point 95% of my pustules had cleared up, with only occasional breakthroughs of a single pustule, so I’ve stayed with once a day treatment. No irritation with the gradual introduction, and it has been the only thing that has ended the “pizza face” look for my face. I have oily skin, which probably helps prevent irritation – though plenty of other things irritate my skin.

    • Frankie Franck says:

      What is the name of the product??

    • Julia says:

      What generic product are you currently using with the 5% BP? I would like to try it also as nothing else has worked since I had a diagnosis over a decade ago.

      Do you also use makeup? If so, what do you use and does it have good coverage without having a cake-like appearance or settling into fine lines? I have oily skin that is also dry at the same time. It is very odd and I have not come across anyone with the same issue except 1 family member (a cousin) without rosacea.

  3. “This is interesting! I know someone who cleared their acne rosacea with a 10% benzoyl peroxide lotion from Target. My skin was too sensitive for BP even before rosacea. Maybe if this is less irritating it would help a lot of people though. I’ve also heard you can buy a foam BP wash, apply the foam to the area 5-10 minutes and then wash the foam off. Might be worth a try for some people”

    “I’ve used BP before and it’s too harsh on my rosacea. I’ll stick with my current regimen.”

  4. Adam says:

    Hello David,
    Is their any news in regards to a treatment targeting Cathelicidin or have any companies expressed interest in pursuing such an approach?

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