By a News Reporter-Staff News Editor at Clinical Trials Week - Castle Creek Pharmaceuticals (CCP), a global company dedicated to delivering transformative therapies to patients with dermatologic and head/neck orphan diseases and underserved conditions, announced that results from a placebo-controlled clinical trial for topical diacerein 1% in the treatment of epidermolysis bullosa simplex (EBS) were presented in a late-breaker session at the American Academy of Dermatology Annual Meeting in Orlando. Results were presented by Professor Johann Bauer, MD, MBA, HCM, head of the University Clinic for Dermatology at the SALK/Paracelsus Medical University and principal investigator in the trial.
The multicenter, randomized, double-blind, placebo-controlled phase 2 trial included 17 patients with EBS who were treated for four weeks followed by three-month follow-up and subsequent cross-over in year two. Results, which were previously reported, showed a 60 percent reduction in blistering among patients treated with diacerein 1% versus a 15 percent reduction in the placebo group at four weeks. At three months, 67 percent of patients in the placebo group returned to baseline blistering levels, versus 12.5 percent of patients in the diacerein 1% treatment group. Topical diacerein 1% was well tolerated with no treatment-related adverse events reported (see also Castle Creek Pharmaceuticals).
"With no treatment options available, management of EBS remains a significant area of unmet need in healthcare. These results represent a historic advance in research related to EBS indicating the potential to bring patients a safe and effective treatment option in the years ahead," said Dr. Bauer. "Importantly, these results also show the potential for diacerein 1% to offer long-term benefits in patients experiencing blistering associated with EBS."
EBS is the most common form of epidermolysis bullosa, a rare dermatologic condition where patients (many of them children) have a genetic defect that compromises the structural integrity of their skin, making it particularly fragile and prone to blistering over their entire bodies. Severe cases of EBS involve widespread blistering that can lead to infections, dehydration, and other medical problems. CCP-020 (diacerein 1% ointment) is an investigational therapy in development at Castle Creek Pharmaceuticals for the treatment of EBS. It is a potentially disease-modifying therapy that blocks an important inflammatory signaling pathway in EBS.
"The results of this important clinical trial for diacerein 1% are another milestone in our plan to identify and advance a pipeline of promising therapies to treat rare and orphan diseases in dermatologic and head/neck indications," said Greg Licholai, MD, president and chief scientific officer at Castle Creek Pharmaceuticals. "We look forward to advancing this development program through the final stages of regulatory review as rapidly as possible in our effort to bring a safe and effective treatment option to patients affected by EBS around the world."
Keywords for this news article include: Castle Creek Pharmaceuticals, Therapy, Placebos, Dermatology, Clinical Research, Skin Abnormalities, Congenital Abnormalities, Clinical Trials and Studies, Epidermolysis Bullosa Simplex, Genetic Skin Diseases and Conditions, Vesiculobullous Skin Diseases and Conditions, Skin and Connective Tissue Diseases and Conditions.
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