A study to evaluate the effects of Sabarep™ cream (zinc lactate1% w/w)

• Research type

  Research Study

• Full title

  A Phase I, open, single-centre, placebo controlled parallel group study to evaluate the effects of topical Sabarep™ cream (1% zinc lactate 1% w/w) on atopic dermatitis lesions, serum zinc levels, and safety and tolerability following a single dose application.

• IRAS ID

  75023

• Contact name

  Brian Leaker

• Sponsor organisation

  Sabareb Ltd

• Eudract number

  2012-000051-14

• ISRCTN Number

  ISRCTN

• Research summary

  This is an open-label study in which each subject will receive a single treatment application with Sabarep?½ cream (zinc lactate1% w/w) and placebo applied to two separate areas of atopic dermatitis lesions. The study will recruit subjects with atopic dermatitis and will be carried out at the Heart Lung Centre, London. 8 subjects will complete the study. Subjects will take part in the study for a minimum of 21 days and a maximum of 38 days. All visits are out-patient visits.Sabarep?½ Cream (1% zinc lactate w/w) is a new cream to be applied to skin area where there is active eczema or atopic dermatitis. It contains zinc as an active ingredient which has been used to treat skin disorders for decades. This study will be the first to use this type of zinc cream and the aim of the study is to find out if the zinc based cream has any effect on skin lesions. The study is also to determine if the application of zinc based cream results in the absorption of zinc in small quantities into the blood stream. There will also be a placebo cream used in this study. Placebo is a ??dummy drug?? that does not contain any active ingredients. Both Sabarep cream and the placebo will be applied to two separate lesions of dermatitis and the effects of the creams on the lesions will be observed and compared.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0308

• Date of REC Opinion

  7 Mar 2012

• REC opinion

  Favourable Opinion