A multiple dose tolerability study of betamethasone cream

• Research type

  Research Study

• Full title

  A 14 day, double-blind, negative and reference controlled, cumulative irritant patch test to evaluate the local tolerability of topical betamethasone dipropionate Biogaran 0.05% cream in healthy volunteers

• IRAS ID

  101540

• Contact name

  Girish Sharma

• Sponsor organisation

  Biogaran

• Eudract number

  2012-000337-39

• Clinicaltrials.gov Identifier

  1

• Research summary

  Biogaran have developed a betamethasone cream for the treatment of eczema and other skin conditions. Betamethasone cream is an anti-inflammatory for the treatment of human skin conditions such as eczema i.e. skin irritation/inflammation caused by an allergic reaction. Anti-inflammatory drugs work by helping to control or reverse the symptoms of inflammation. The purpose of this study is to see if the new betamethasone cream, a marketed betamethasone cream and a control product, cause any skin reactions when applied for 14 days to normal healthy skin. We will measure the extent by which the creams cause skin reactions by assessing for signs of skin redness or irritation.

• REC name

  Wales REC 1

• REC reference

  12/WA/0066

• Date of REC Opinion

  13 Mar 2012

• REC opinion

  Further Information Favourable Opinion