Evaluating Altoderm in Paediatric Atopic Dermatitis

• Research type

  Research Study

• Full title

  A multi-centre, double-blind, placebo-controlled, randomised group comparative study to evaluate the efficacy and safety of Altoderm, a topically applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children.

• IRAS ID

  7379

• Contact name

  John Berth-Jones

• Sponsor organisation

  Thornton & Ross Ltd

• Eudract number

  2008-005469-67

• ISRCTN Number

  Not yet registered

• Research summary

  This study is looking at the safety and effectiveness of a new lotion in the treatment of children aged between 2 and 12 years suffering from eczema. The new lotion will be compared against a placebo (hereon known as 'vehicle') lotion and the results measured primarily using a specific scoring system called SCORAD. The vehicle is the emollient base (lotion) for Altoderm (test treatment) without the active (4% sodium cromoglicate). The SCORAD system is an established and valid visual assessment of the severity of eczema. A further secondary scoring system (SASSAD) and quality of life questionnaires will also be completed by the child or their parent/guardian as appropriate.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/57

• Date of REC Opinion

  20 Jan 2009

• REC opinion

  Further Information Favourable Opinion