Palmoplantar Pustulosis (PPP) Case Study

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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

     

    Challenges

    Solutions

    Dermatology service icon

     

    Site Selection

    • Identification of sites due to limited pool of patients with rare diseases
      • 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

    Phone job interview

     

    Recruitment

    • Participant apprehension regarding biopsy consent
    • Hassle of transporting IP between site and patient's home
    • Short treatment period deterred interest in participation
      • 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

During the clinical study icon Activation of sites in Germany to bolster recruitment

During the clinical study icon Effective in-house central campaigns

During the clinical study icon Project team’s tremendous engagement with sites to drive recruitment

 


 

Recruitment Curve and Site Activation

 

Enrollment was completed 3 weeks earlier than planned

 


 

 

Contact us

Innovaderm Research Wave