Outcomes
Innovaderm successfully managed this PPP study and this resulted in:
- Enrollment completed 3 weeks ahead of schedule; Successful study and satisfied sponsor
Study Characteristics
- Study Phase: II
- Patient Population: Palmoplantar pustulosis
- IP Route of Administration: Systemic
- Sites Distribution: 17 sites in 2 countries (Canada, Germany)
- Study Complexities: Presence of active lesions required, high PPPASI and PPPGA
Study Challenges and Solutions
Challenge 1: Site Selection
Identification of sites due to limited pool of patients with rare diseases
Solutions
- Early activation of sites in Germany
- Timely assessment of potential challenges with site selection
- Implementation of in-house central campaign
Outcome
- Enrollment completed 3 weeks ahead of schedule
Challenge 2: Recruitment
- Participant apprehension regarding biopsy consent
- Hassle of transporting IP between site and patient’s home
- Short treatment period deterred interest in participation
Solutions
- Strong presence of on-site staff to address questions or concerns related to participation
Outcome
- Successful study and satisfied sponsor (+40%)
Key Success Factors & Strategies
- Activation of sites in Germany to bolster recruitment
- Effective in-house central campaigns
- Project team’s tremendous engagement with sites to drive recruitment
