20th Sep 2006 07:01
Sinclair Pharma PLC20 September 2006 Sinclair Pharma plc Announces Positive Results of AtopiclairTM Pediatric Study in US Results Demonstrate Safety, Efficacy and Steroid Sparing Effect 20 September 2006, Godalming. Sinclair Pharma plc (SPH.L), the specialtypharmaceutical company, today announced positive results of a new US pediatricstudy for its atopic dermatitis product, AtopiclairTM. The multicentre, double-blind, randomized, vehicle-controlled, 142-patientclinical trial demonstrated significant improvement of mild to moderate atopicdermatitis (eczema), for infants and children (between the ages of 6 months and12 years) treated with AtopiclairTM cream versus an emollient vehicle cream.It also showed that patients using AtopiclairTM needed less steroid rescuetreatment during the study compared to the emollient group. The results support the use of AtopiclairTM in younger patients, whereclinicians are more reluctant to prescribe topical steroids and need products toprovide fast relief from the itch associated with atopic dermatitis.Approximately a third of atopic dermatitis prescriptions are for pediatricpatients(i) and this data will provide support to Sinclair's US marketingpartner, Chester Valley Pharmaceuticals, Inc, the company's own sales force inItaly, and other global partners, to build sales for AtopiclairTM. Study results The primary endpoint of the study was 'treatment success', defined by whetherthe patient was either 'clear' or 'almost clear' of atopic dermatitis after 22days. 77% (53 out of 69) patients using AtopiclairTM were considered 'treatmentsuccesses' and at the same time point there were no treatment successes in thecontrol group (pRelated Shares:
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