New Variety of Steroid Treatment For Dermatitis
SkinMedica, Inc., announced today the positive outcome of two Phase III clinical trials evaluating Desonate (desonide) HydroGel 0.05%, a low-potency topical steroid formulated in a proprietary alcohol-free, aqueous gel delivery vehicle to treat atopic dermatitis. SkinMedica, Inc. is a specialty pharmaceutical company focused on developing, acquiring and commercializing products that improve the appearance of skin and treat dermatologic conditions and diseases.
The Desonate Phase III studies were conducted as a multi-center, randomized, double-blind, placebo-controlled comparison involving pediatric subjects with mild to moderate atopic dermatitis. These clinical trials included 582 patients from age 3 months to 18 years, and were designed to demonstrate superiority of Desonate HydroGel over vehicle (placebo) without desonide. Patients received either Desonate HydroGel or placebo twice daily for four weeks.
The results of these two studies demonstrated a consistently robust and highly statistically significant treatment effect for Desonate compared to placebo in both primary and secondary end-points. These included Investigator Global Severity Assessment (IGSA) along with the alleviation of signs and symptoms of atopic dermatitis, including erythema, induration/papulation, and scaling. The proportion of patients achieving treatment success using the IGSA primary end-point was 44% for Desonate HydroGel and 14% for the vehicle group in the first trial. In the second trial, treatment success rates were 28% for Desonate HydroGel and 6% for the vehicle group. The p value for each of these comparisons was p less than 0.001.
The data from these trials also demonstrated that Desonate HydroGel was well-tolerated, with the most frequently observed side effects being mild in nature and largely limited to application site reactions. There were no serious adverse events reported. Overall, the safety analysis revealed no unexpected findings for a topical agent of this type.
"We are very enthusiastic about the robust results of these Desonate HydroGel pivotal trials," said Ron Trancik, PhD, Vice President of Research and Development for SkinMedica. "We are particularly excited about this new, low-potency steroid formulation with desonide, in a novel patented aqueous vehicle. HydroGel will offer dermatologists and their patients, particularly younger children, a product with enhanced properties which we believe will lead to increased patient compliance and satisfaction."
"The collaboration between SkinMedica and Dow Pharmaceutical Sciences is an excellent example of how two companies can work together in planning and executing an important development project," said Rex Bright, Chief Executive Officer of SkinMedica. "We will be seeking approval to market Desonate HydroGel in the United States."
Desonide is a leading topical steroid prescribed by dermatologists within the U.S. low-potency steroid market which generates 7.7 million annual prescriptions. If approved, Desonate HydroGel would provide SkinMedica with its first steroid product in the $1.1 billion topical steroid market. SkinMedica believes that the HydroGel delivery system has important advantages over more conventional drug delivery vehicles. Conventional steroid formulations including gels and foams typically contain alcohol that may be irritating to patients with atopic dermatitis. HydroGel, an aqueous-based and alcohol-free system, has been developed by Dow Pharmaceutical Sciences to compete against the conventional formulations as a functionally and cosmetically acceptable delivery system. Patients in the clinical trial noted that the HydroGel formulation helped to relieve dryness, which is often a problem with atopic dermatitis. The patented HydroGel drug-delivery technology was licensed by SkinMedica from Dow Pharmaceutical Sciences in June 2003 for use with desonide. The development of Desonate HydroGel is a collaborative effort between Dow Pharmaceutical Sciences and SkinMedica. In April 2005, the companies expanded their collaboration in which SkinMedica licensed the rights to apply the HydroGel technology to certain other prescription steroids worldwide.
The Desonate Phase III studies were conducted as a multi-center, randomized, double-blind, placebo-controlled comparison involving pediatric subjects with mild to moderate atopic dermatitis. These clinical trials included 582 patients from age 3 months to 18 years, and were designed to demonstrate superiority of Desonate HydroGel over vehicle (placebo) without desonide. Patients received either Desonate HydroGel or placebo twice daily for four weeks.
The results of these two studies demonstrated a consistently robust and highly statistically significant treatment effect for Desonate compared to placebo in both primary and secondary end-points. These included Investigator Global Severity Assessment (IGSA) along with the alleviation of signs and symptoms of atopic dermatitis, including erythema, induration/papulation, and scaling. The proportion of patients achieving treatment success using the IGSA primary end-point was 44% for Desonate HydroGel and 14% for the vehicle group in the first trial. In the second trial, treatment success rates were 28% for Desonate HydroGel and 6% for the vehicle group. The p value for each of these comparisons was p less than 0.001.
The data from these trials also demonstrated that Desonate HydroGel was well-tolerated, with the most frequently observed side effects being mild in nature and largely limited to application site reactions. There were no serious adverse events reported. Overall, the safety analysis revealed no unexpected findings for a topical agent of this type.
"We are very enthusiastic about the robust results of these Desonate HydroGel pivotal trials," said Ron Trancik, PhD, Vice President of Research and Development for SkinMedica. "We are particularly excited about this new, low-potency steroid formulation with desonide, in a novel patented aqueous vehicle. HydroGel will offer dermatologists and their patients, particularly younger children, a product with enhanced properties which we believe will lead to increased patient compliance and satisfaction."
"The collaboration between SkinMedica and Dow Pharmaceutical Sciences is an excellent example of how two companies can work together in planning and executing an important development project," said Rex Bright, Chief Executive Officer of SkinMedica. "We will be seeking approval to market Desonate HydroGel in the United States."
Desonide is a leading topical steroid prescribed by dermatologists within the U.S. low-potency steroid market which generates 7.7 million annual prescriptions. If approved, Desonate HydroGel would provide SkinMedica with its first steroid product in the $1.1 billion topical steroid market. SkinMedica believes that the HydroGel delivery system has important advantages over more conventional drug delivery vehicles. Conventional steroid formulations including gels and foams typically contain alcohol that may be irritating to patients with atopic dermatitis. HydroGel, an aqueous-based and alcohol-free system, has been developed by Dow Pharmaceutical Sciences to compete against the conventional formulations as a functionally and cosmetically acceptable delivery system. Patients in the clinical trial noted that the HydroGel formulation helped to relieve dryness, which is often a problem with atopic dermatitis. The patented HydroGel drug-delivery technology was licensed by SkinMedica from Dow Pharmaceutical Sciences in June 2003 for use with desonide. The development of Desonate HydroGel is a collaborative effort between Dow Pharmaceutical Sciences and SkinMedica. In April 2005, the companies expanded their collaboration in which SkinMedica licensed the rights to apply the HydroGel technology to certain other prescription steroids worldwide.
posted by Madison @ 8:15 AM
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