A Post Market Clinical Follow Up Study to Assess Perfectha Subskin Lid

• Research type

  Research Study

• Full title

  A Post Market Clinical Follow Up (PMCF) Study to Assess the Safety and Efficacy of Use of Perfectha Subskin Lidocaine in the Treatment of Significant Loss of Volume in the Cheeks, Jawline and/or Chin

• IRAS ID

  323072

• Contact name

  Stuart Boothman

• Contact email

  sboothman@sinclair.com

• Sponsor organisation

  Sinclair Pharmaceuticals Ltd

• ISRCTN Number

  ISRCTN63865080

• Duration of Study in the UK

  1 years, 8 months, 30 days

• Research summary

  This study is a Post Market Clinical Follow Up study, aims to generate a coherent clinical data set to demonstrate the efficacy and safety of Perfectha Subskin Lidocaine as a treatment for significant loss of volume in the cheeks, jawline and/or chin.
  Cumulative changes over time in multiple structural facial tissue layers lead to a change in morphology of the entire face in terms of shape, proportions, and topography. Integration of volume replacement into the surgical and non-surgical therapeutic algorithm as a treatment for volume loss during aging is the most important recent development in field of facial rejuvenation. The key molecule involved in skin moisture is hyaluronic acid (HA), a glycosaminoglycan (GAG) with a unique capacity to bind and retain water molecules. During facial aging, the most dramatic histochemical change observed is the marked disappearance of epidermal HA , while dermal HA is still present.
  Perfectha Subskin Lidocaine is indicated for significant loss of volume in areas such as cheekbones, chin, jawline, temples, forehead, bridge of the nose and hands. The device is intended to be administrated via injection into the deep subcutaneous fat tissue and/or into the superpatriots zone by an authorized health professional. Lidocaine is a component within the gel, included to reduce pain resulting from injection during the treatment.
  The study will be conducted in 2 study sites located in the UK. The study consists of 6 visits to assess efficacy and safety at month 1, 3,6,9,12, and 18. The trial requires 60 subjects that complete the study visits. 23 subjects will be assigned to each treatment group (i.e., cheeks, jawline or chin). The subject will have a primary treatment area and that will be the treatment group they will be assigned to. Male or female patients between the ages of 25 and 65 years of age inclusively across a range of Fitzpatrick skin types presenting significant loss

• REC name

  HSC REC B

• REC reference

  22/NI/0185

• Date of REC Opinion

  22 Dec 2022

• REC opinion

  Further Information Favourable Opinion