Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Sol-Gel Completes Successful Phase II Study in Rosacea

Published: Wednesday, December 05, 2012
Last Updated: Wednesday, December 05, 2012
Bookmark and Share
Company plans to initiate Phase III studies for E-BPO next year.

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.

Study Results
"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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,100+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Investigational Malaria Vaccine Protects Healthy U.S. Adults
Researchers at NIH have found that the malaria vaccine protected a small number of healthy, malaria-naïve adults in the U.S. from infection for more than one year after immunization.
AACR 2016: Cancer Immunotherapy and Beyond
At this year's meeting there was a palpable buzz around subjects ranging from microbiomics to the tumor microenvironment and cancer vaccines, big data to in vitro and in vivo modeling and drug delivery (to name just a few).
New Database for Sharing MS Clinical Trial Data
A new database containing nearly 2500 patient records from the placebo arms of nine multiple sclerosis (MS) clinical trials is now available for research by qualified investigators.
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
BMS’s Opdivo Clinical Trial Shows Promise
Safety profile of the combination regimen from CheckMate -069 was consistent with previously reported studies and adverse events were managed using established safety algorithms.
Treatment of Common Prostate Cancer
Researchers at UTSW have found that the prostate cancer treatments suppress immune response and may promote relapse.
Cancer Drug Could Treat Blood Vessel Deformities
A drug currently being trialled in cancer patients could also be used to treat an often incurable condition that can cause painful blood vessel overgrowths inside the skin.
Structure of Crucial Enzyme Identified
Researchers at UTSW have determined the atomic structure of an enzyme that plays an essential role in cell division and better treatment of cancer.
New Immunotherapy Trial for Type 1 Diabetes
The search for a treatment for Type 1 diabetes (T1D) - which affects over 400,000 people in the UK – will be stepped up with the start of a new phase one clinical trial at Guy’s Hospital in London.
Recruitment of First Patient in Clinical Study
Company has announced recruitment of first patient in clinical study assessing Visco-ease with Beatson Cancer Centre for the treatment of RIX.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!