(duplicate) Repeat Insult Patch Test for Clobetasone Butyrate Ointment

• Research type

  Research Study

• Full title

  A Repeat Insult Patch Test (RIPT) To Determine The Cutaneous Irritancy Of Eumovate® Ointment And A Generic Form Of Clobetasone Butyrate 0.05% w/w Ointment In Volunteer Subjects.

• IRAS ID

  65614

• Contact name

  Ronald marks

• Sponsor organisation

  Pharmaserve R&D Ltd

• Eudract number

  2010-022892-69

• ISRCTN Number

  1

• Research summary

  The study is designed to assess whether a new generic formulation of clobetasone butyrate 0.05% w/w ointment produces any reactions of an irritant nature when applied to the skin of healthy volunteerisubjects.The design of the study is that of a "repeat insult patch test" (RIPT).In'such a design, test materials are applied continually under occlusion to the same site (six applications to the same site over a 14 day period).Such an approach maximises the cutaneous insult and is designed to reveal low orders of irritancy.

• REC name

  Wales REC 1

• REC reference

  10/WSE04/57

• Date of REC Opinion

  13 Jan 2011

• REC opinion

  Further Information Favourable Opinion