Open Label Study of QRX003 Lotion in Subjects with Netherton Syndrome

• Research type

  Research Study

• Full title

  A Multicenter, Open Label Study of QRX003 Lotion in Subjects with Netherton Syndrome

• IRAS ID

  1011302

• Contact name

  Michael Myers

• Contact email

  mmyers@quoinpharma.com

• Sponsor organisation

  Quoin Therapeutics (Ireland) Limited

• Clinicaltrials.gov Identifier

  NCT05789056

• Research summary

  The study will assess safety and tolerability of a novel Investigational Medicinal Product (IMP) QRX003 (dipalmitoyl hydroxyproline) skin lotion in comparison to a vehicle in subjects with Netherton Syndrome (NS).
  The study is divided into 2 parts - A and B.
  Part A of the study will evaluate the safety, tolerability, and efficacy of QRX003 lotion 4% applied once daily, in the morning (QAM). Part B of the study will evaluate the safety, tolerability, and efficacy of QRX003 lotion 4% applied twice daily (BID). In both parts, participants will continue their standard of care treatment including their systemic therapy . The study procedures, visit schedules, and assessments will be the same in both parts, Part A and Part B.
  The patients will have 12 weeks treatment and 6 weeks follow up. The study will recruit 20 participants of age 14 years and older. Participants will require to complete 5 study visits: Screening, Baseline, Week 6, Week 12 / End of Treatment and Week 16 / End of Study.

• REC name

  London - Central Research Ethics Committee

• REC reference

  25/LO/0231

• Date of REC Opinion

  28 May 2025

• REC opinion

  Further Information Favourable Opinion