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.
Cell Recycling System Offers Therapeutic Entry Point for Rare Disease TreatmentNews
Scientists have demonstrated how an investigational drug works against a rare, fatal genetic disease, Niemann-Pick type C1 (NPC1).READ MORE
Bone Cancer Drug Targets Tumors, Spares Other OrgansNews
A study led by The University of Texas MD Anderson Cancer Center found a drug known as bone metastasis-targeting peptidomimetic (BMTP-11) has potential as a new therapeutic strategy for this devastating illness.READ MORE
Cancer Cells Force Normal Cells to Act Like Viruses, Helping Tumors SpreadNews
Researchers reveal how cancer cells force normal cells to act like viruses – allowing tumors to grow, resist treatment, and spread.READ MORE
Comments | 0 ADD COMMENT
EMBL Conference: European Conference of Life Science Funders and Foundations
Apr 19 - Apr 20, 2018
EMBL Course: Target Engagement in Biology and Drug Discovery
Feb 19 - Feb 23, 2018