22nd Nov 2006 07:00
Sinclair Pharma PLC22 November 2006 Sinclair Pharma plc Announces Further Positive Trial Results of Atopiclair(TM) against Atopic Dermatitis in Children. Results Confirm Safety, Efficacy and Steroid-Sparing Effect 22 November 2006, Godalming. Sinclair Pharma plc (SPH.L), the specialtypharmaceutical company, today announced positive results from a new Europeanpaediatric study for its atopic dermatitis product, Atopiclair(TM). Theproduct has regulatory approval in both the EU and the USA. The multicentre, double-blind, randomized, emollient-controlled clinical trialdemonstrated significant improvement of mild to moderate atopic dermatitis(eczema), for adolescents and children (between the ages of 2 and 17 years)treated with Atopiclair(TM) cream versus an emollient vehicle cream. 20patients were recruited into the Atopiclair group and 20 to the control group. Atopic dermatitis (also known as eczema) is one of the most commondermatological complaints affecting approximately 20% of school aged childrenand up to 3% of adults. Current treatments for atopic dermatitis includetopical corticosteroids or topical immunomodulators, which may have unfavourableside effects. Study results The study treatments were continued for 43 days and there was a wide range ofsecondary response criteria. The primary endpoint of the study was 'treatmentsuccess', defined by the patient being either 'clear' or 'almost clear' ofatopic dermatitis after 22 days. 80% (16 out of 20) patients usingAtopiclair(TM) were considered 'treatment successes' compared to 26% (5/19) ofpatients receiving the emollient cream, (p=0.001) at the same time point. (Onepatient in the control group was withdrawn from the trial before 22 days). Secondary outcomes included the need for rescue medication with a topicalcorticosteroid, in the event of a flare-up during the study period. In theAtopiclair(TM) group, only one patient (5%) needed rescue medication with asteroid cream, compared to seven (35%) in the control group (pRelated Shares:
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