Atopic Dermatitis (AD) Case Study

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AD case study


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Outcomes

Innovaderm successfully managed this AD study

and this resulted in:

Enrollment completed 2 months earlier than planned;
Innovaderm CRU recruited 33% of patients


 

Study Characteristics

    • Study Phase: Ib
  • Patient Population: 36 subjects with moderate to severe AD
  • IP Route of Administration: Systemic - Oral
  • Site distribution: 10 sites in 2 countries (USA and Canada)
  • Study Design: Randomized, sequential, placebo-controlled, double-blind | Multiple ascending dose (MAD): 3 sequential cohorts
  • Study procedures: 4.5 mm punch skin biopsies, photographs, biomarker analysis, skin microbiome, pharmacokinetics, tape stripping and efficacy-safety assessments

 


 

Study Challenges

    • Recruitment during summer months; Seasonality impacts on AD flares
    • Short treatment duration; 4-week treatment period
    • Data and Safety Monitoring Board (DSMB) after each cohort; Challenging to manage without affecting recruitment

 


 

Key Success Factors & Strategies

Phone interview icon Recruitment completed in 6 months vs planned 8 months

Site engagement Outstanding contribution by Innovaderm's Clinical Research Unit

 


 

Recruitment Curve

 

Enrollment target reached 2 months ahead of schedule

 


 

     

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