Acne Case Study

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Acne case study


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Outcomes

Innovaderm successfully managed this acne study and this resulted in:

Enrollment completed 1 month earlier than planned


 

Study Characteristics

  • Study Phase: II
  • Patient Population: Acne vulgaris (enrolling pediatrics & adults)
  • IP Route of Administration: Systemic
  • Sites distribution: 15 sites (USA)

 


 

Study Challenges and Solutions

 

Challenges

Solutions

Dermatology service icon

 

Administration mode
Use of a novel route of administration for a population accustomed to topical and oral treatments

    • Promoting the new treatment and clarity of messaging with the sites
    • Careful selection of sites

Outcome: Enrollment completed one month ahead of schedule

Phone job interview

 

Recruitment - Apprehension
Enrollment of pediatric population while managing patients' and their parents' fears regarding the route of administration

    • Experience with pediatric enrollment was mandatory for sites
    • As minors tend to have compliance issues, the administration of a drug once every two weeks was a key advantage

Outcome: Recruited much more pediatrics than expected (+40%)

Dermatologist and clinical site icon

 

Pandemic
Enrolling during the first waves of  COVID-19 could have impacted recruitment & operations (site staffing, monitoring visits, etc.)

    • Sites were prepared to operate and follow new safety guidelines regarding COVID-19

Outcome: The study proceeded as scheduled


 

Key Success Factors & Strategies

Site selection symbol Local advertisement campaigns to increase engagement

During the clinical study icon Implemented remote monitoring during COVID-19 to maintain workflow efficiency

 


 

Recruitment Curve and Site Activation

 

Randomization target reached 1 month earlier than planned on our ambitious timeline

 


 

Our Key to Success

Workflow efficiency   Engaged sites  •  First-in-class therapy

     

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