SPARK - PMCF questionnaire-based study for Hydromol Intensive

• Research type

  Research Study

• Full title

  ObServational, Questionnaire-based Post-Market Clinical Follow-Up (PMCF) study retrospectively assessing the Performance and sAfety of HydRomol® Intensive in the treatment of dry sKin

• IRAS ID

  348168

• Contact name

  Vera Kachko

• Contact email

  Vera.Kachko@allianceph.com

• Sponsor organisation

  Alliance Pharmaceuticals Limited

• Duration of Study in the UK

  0 years, 4 months, 8 days

• Research summary

  This is a clinical evaluation of an already marketed, CE-marked (Certified Europe Marked) medical device which will be used in this study in accordance with its certified intended purpose. This study forms part of Alliance Pharmaceuticals’ post market surveillance obligations for the purposes of confirming the Hydromol Intensive’s (Available as Hydromol Intensive and Aquadrate Cream) ongoing safety and performance for its indicated populations, in its CE marked dry skin condition indications (ichthyosis, xerosis, atopic dermatitis/eczema, contact dermatitis, psoriasis, seborrheic dermatitis, keratosis and pruritus) in accordance with Part B Annex XIV of Medical Device Regulation (MDR) EU/2017/745.
  
  Potentially eligible participants who were prescribed Hydromol Intensive to treat a dry skin condition for at least 4 weeks between 1st October 2018 and 30th September 2023 will be identified using agreed search criterion codes from GP practices’ clinical databases. Participating NHS GP practices will act as Participant Identification Centres (PICs) for this survey. PIC staff will distribute a SMS text message (using a REC-approved narrative) to the identified potentially eligible participants (or their parent/legal guardian if <18 years old) with an invitation and a link to complete a short web-based survey. Data will be collected on a voluntary basis via the single questionnaire filled in directly by the eligible participant (or their parent/legal guardian if <18 years old).

  The survey will aim to capture one completed online questionnaire from each participant (approximately 385) in England.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  24/PR/1153

• Date of REC Opinion

  6 Nov 2024

• REC opinion

  Further Information Favourable Opinion