Sol-Gel Completes Successful Phase II Study in Rosacea
News Dec 05, 2012
Sol-Gel Technologies Ltd. has announced 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 study results, could change the way physicians treat rosacea," said Dr. Alon Seri-Levy, Sol-Gel’s co-founder and CEO.
Noting that encapsulated benzoyl peroxide (E-BPO) is the first drug in Sol-Gel's pipeline of innovative topical dermatological drugs to complete Phase II studies, he added: "We plan to initiate Phase III studies for E-BPO next year".
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.