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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
Challenge 1: Administration Mode
Use of a novel route of administration for a population accustomed to topical and oral treatments
Solutions
- Promoting the new treatment and clarity of messaging with the sites
- Careful selection of sites
Outcome
- Enrollment completed one month ahead of schedule
Challenge 2: Recruitment – Apprehension
- Enrollment of pediatric population while managing patients’ and their parents’ fears regarding the route of administration
Solutions
- 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%)
Challenge 3: Pandemic
- Enrolling during the first waves of COVID-19 could have impacted recruitment & operations (site staffing, monitoring visits, etc.)
Solutions
- Sites were prepared to operate and follow new safety guidelines regarding COVID-19
Outcome
- The study proceeded as scheduled
Key Success Factors & Strategies
- Local advertisement campaigns to increase engagement
- Implemented remote monitoring during COVID-19 to maintain workflow efficiency
