Randomized, Double-blind Study of QRX003 Lotion in Subjects with Netherton Syndrome
Research type
Research Study
Full title
A Multicenter, Randomized, Vehicle-Controlled, Double-Blind, Parallel Comparison, Proof-of-Concept Study of QRX003 Lotion in Subjects with Netherton Syndrome
IRAS ID
1011671
Contact name
Michael Myers
Contact email
Sponsor organisation
Quoin Therapeutics (Ireland) Limited
Clinicaltrials.gov Identifier
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) in comparison to vehicle lotion.
Part B of the study will evaluate the safety, tolerability, and efficacy of QRX003 lotion 4% applied twice daily (BID) in comparison to vehicle lotion. 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 treatments and 6 weeks follow up. The study will recruit 30 participants of age 14 years and older. Participants will be required 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/0232
Date of REC Opinion
13 May 2025
REC opinion
Further Information Favourable Opinion