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

   

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  Study Challenges and Solutions

  		Challenges		Solutions
  		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
  		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

Activation of sites in Germany to bolster recruitment

Effective in-house central campaigns

Project team’s tremendous engagement with sites to drive recruitment

Recruitment Curve and Site Activation

Enrollment was completed 3 weeks earlier than planned

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