Study Characteristics
- Study Phase: II
- Patient Population: 126 patients with Notalgia Paresthetica (NP) (Pruritus associated with NP)
- IP Route of Administration: Systemic (oral)
- Site Distribution: 33 sites (USA and Canada)
- Study Procedures: Photographs, Pharmacokinetics, Electrocardiograms
Study Challenges and Solutions
- Patient awareness: Challenge in advertisement as patients are often unaware of the name of their condition
- Run-in period (screening): To ensure the enrollment of highly compliant patients and those with consistent itch
- Patient compliance: Primary endpoints were relying on patient-reported assessments
- Uncommon indication: PI with little experience in this indication
Study Highlights
- Increased support for low-performing sites
Engaged with low-enrolling sites to ensure proper use of their local campaign budget - Creative advertising
Digital and local innovative marketing tactics to encourage patients to participate - Notalgia paresthetica cro specialty
Innovaderm managed 100% of the notalgia paresthetica studies (as per clinical trials.gov) - High compliance rate
Additional patient compensation for fully completed diary