Sol-Gel Releases E-BPO Phase 2 Trial Notes

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In July 2009 we learned that Ness Ziona, Israel based Sol-Gel was trialing a supposed Benzoyl Peroxide derivate DER 45 EV for the treatment of rosacea.

Sol-Gel was granted Investigational New Drug Application for DER45-EV in November 2009, which allowed Sol-Gel to undertake Phase 2 Trials. DER45-EV has been licensed to a US based Pharmaceutical company (looks to be Merck) to further develop the drug and bring it to market.

It appears that DER45-EV is now being called encapsulated benzoyl peroxide (E-BPO).

The 5% formulation was found to  be the most effective with 53% of participants being classed as clear or almost clear of rosacea symptoms. The average reduction in rosacea lesion count was 69%.

This is potentially good news for rosacea sufferers, especially those with stubborn papules and pustules that might benefit from a slow release form of benzoyl peroxide.

Press Release

Sol-Gel Completes Successful Phase II Study in Rosacea

Ness Ziona, Israel, December 5, 2012 / B3C newswire / – Sol-Gel Technologies Ltd. announced today positive results for a Phase II trial in the U.S. targeting mild-to-severe rosacea using a benzoyl peroxide drug product developed by Sol-Gel. Although benzoyl peroxide is an established treatment for acne, until now it has not been used for the treatment of rosacea because it causes a high degree of skin irritation. Sol-Gel’s proprietary silica-based microencapsulation drug delivery system, successfully demonstrated in the study that it can ultimately provide a safe and effective first-in-class treatment.

The double-blind, randomized, vehicle-controlled, dose-range study was carried out at eight medical centers in the U.S. on 92 rosacea patients. The patients received one of two doses of E-BPO or a vehicle gel (control group). The length of the treatment was 12 weeks. The two tested doses were 1% and 5% E-BPO.

The primary objective of the study was to identify the lowest dose of E-BPO gel that demonstrates both safety and effectiveness in the treatment of rosacea.

There were two primary efficacy endpoints: the proportion of subjects with the primary measure of success, defined as a 2-grade improvement in the Investigator Global Assessment (IGA) relative to Baseline at Week 12, with patients at Week 12 IGA being clear or almost clear of symptoms; and the change in inflammatory lesion count at Week 12.

In the current study, 53 percent of the patients treated with doses of 5% E-BPO achieved the primary success criteria compared to 20 percent of the vehicle control group.

Reduction in mean inflammatory lesion count was 69 percent for the 5% E-BPO group compared to 33 percent in the vehicle control group.

5% E-BPO gel showed a favorable safety profile and was well tolerated.

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About the Author

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

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2 Reader Comments

  1. John Harcourt says:

    As I said, the article sounds very promising. I hope the results of the tests confirm that it is effective, and has little or no side effects. I have mild Rosacea, caused by a serious operation that compromised my immune system. It has gotten to the stage of Ocular Rosacea. I am going to see my doctor in a few days. I have left my Rosacea for over 5 years now and I am going to ask him for an oral anti-biotic that I have been on before with no side effects for a bad infection called Cellulitis. There is also a cream made by the same company that I am going to ask for also. It is showing great results.

    John.

  2. Rosybean says:

    I’m wondering how this would be with sensitive skin… I can’t generally use benzoyl peroxide, salicylic acid, clindomyacin, azaleic acid, etc. Ziana was what catapulted my rosacea into an advanced stage at the age of 19, so I’m always so nervous about putting new topicals on my skin.

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