DELP-02

• Research type

  Research Study

• Full title

  Comparison of a "long-lasting" emollient with Diprobase cream in subjects with dry skin

• IRAS ID

  62730

• Contact name

  Suzana Louth

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The trial will involve in the region of 40 subjects with dry skin. The subjects will take part concurrently in two cohorts and their participation will span a two to three week period. The study design is a double blind comparison whereby each subject will test both treatments at the same time, applying each emollient to designated areas of their arms/legs in random left/right allocation. The trial comprises two parts. For part 1, lasting 24 hours at the centre with subjects returning home over night, single applications of the two emollients will be applied to subjects?? forearms, and non-invasive instrumental measurements of skin hydration will be repeated eight times over the period. For part 2, to commence approximately one week later (on a Monday), the treatment regimen will involve twice daily application to the lower legs for five consecutive days. Subjects will be asked to restrict bathing/showering or washing their legs to the Tuesday and Thursday only, and only in the evening. Non-invasive instrumental measurements of skin hydration will be repeated twice daily (during visits to the centre), and at the end of the treatment subjects will be asked to complete a questionnaire regarding the cosmetic acceptability of the two emollients. The performances of the two products are to be compared mainly by area under the curve analysis of the skin hydration measurements over time, and in terms of their acceptability ratings.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/24

• Date of REC Opinion

  15 Sep 2010

• REC opinion

  Further Information Favourable Opinion