Open Label Study of QRX003 Lotion in Subjects with Netherton Syndrome not receiving systemic therapy

• Research type

  Research Study

• Full title

  A Multicenter, Open Label Study of QRX003 Lotion in Subjects with Netherton Syndrome who are not receiving systemic therapy.

• IRAS ID

  1012515

• Contact name

  Michael Myers

• Contact email

  mmyers@quoinpharma.com

• Sponsor organisation

  Quoin Therapeutics (Ireland) Limited

• Research summary

  The study will assess safety and tolerability of a novel Investigational Medicinal Product (IMP) QRX003 (dipalmitoyl hydroxyproline) skin lotion in subjects with Netherton Syndrome, who are not receiving systemic therapy.
  This study will evaluate the safety, tolerability and efficacy of QRX003 lotion 4% applied twice daily (BID).
  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

  South Central - Berkshire Research Ethics Committee

• REC reference

  25/SC/0255

• Date of REC Opinion

  26 Sep 2025

• REC opinion

  Further Information Favourable Opinion