SPLASH/In-home use study in babies

• Research type

  Research Study

• Full title

  In-home use test of the new modified Diprobase® formulation to assess the safety and tolerability in infants and children under physician's control

• IRAS ID

  238788

• Contact name

  Catherine Effingham

• Contact email

  c.effingham@nhs.net

• Sponsor organisation

  Bayer Consumer Care AG

• Clinicaltrials.gov Identifier

  NCT03441568

• Duration of Study in the UK

  0 years, 2 months, 3 days

• Research summary

  The study is intended to investigate the safety and tolerability of the modified Diprobase® formulation in infants and children with a history of atopic dermatitis (AD). This study will be done at one site in the UK and will involve 38 participants.
  Participation in the study will last fourteen days. At the end of the study, the study device will not be available to the participants.

  Participants who meet the following eligibility criteria will be included in the research study:
  1. Children with normal or dry skin and a history of mild to moderate atopic dermatitis (AD), but without any signs or symptoms within the last month prior to participation
  2. Children with skin type I – VI according to Fitzpatrick scale (skin type classification system for assessment of sun sensitivity)
  3. Children aged 6 months to 48 months

  During the study the participants parent/guardian of the participant will need to topically administer Diprobase advanced cream to their child twice daily over 14 days. Participant's skin status will be assessed at the baseline visit and also after 7 days and 14 days by the study doctor. The parent/guardian of the participant will also be required to complete a daily diary in order to confirm the use of the product and also at the end of the study they will be asked to provide feedback on their appreciation of the product, its properties and future use.

  The investigator will assess Adverse events and the tolerability of the new investigational medical device.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  18/NW/0088

• Date of REC Opinion

  23 Apr 2018

• REC opinion

  Further Information Favourable Opinion