Key Highlights
Achieving Complete Enrollment in Approximately Four Months
Clarenta supported an investigator-blind, randomized, vehicle-controlled, dose-escalation Phase I study evaluating the safety, tolerability and pharmacokinetics of an investigational topical therapy in adults with mild-to-moderate atopic dermatitis.
Through targeted recruitment and close coordination among dermatology specialists, clinical pharmacology experts and our Phase I Unit, we recruited the complete planned study population within approximately four months.
The Challenge:
The study required adults who met specific clinical criteria for mild-to-moderate atopic dermatitis.
The trial also presented several clinical and operational challenges:
- A specific dermatology population needed to be identified and screened
- Recruitment had to support sequential dose-escalation cohorts
- Intensive systemic and local pharmacokinetic assessments were required
- Time-sensitive assessments needed close coordination
- Recruitment and study activities had to remain aligned with the cohort schedule
- Consistent clinical oversight was required throughout study delivery
Our Solution:
We implemented a targeted recruitment and clinical pharmacology support model. Our team:
- Developed a recruitment strategy for adults with mild-to-moderate atopic dermatitis
- Identified participants who met the study’s specific dermatological criteria
- Coordinated recruitment specialists, investigators and our Phase I Unit
- Supported efficient participant screening
- Managed recruitment across the sequential dose-escalation cohorts
- Provided clinical monitoring throughout study delivery
- Coordinated the complex assessment schedule
- Supported intensive systemic and local pharmacokinetic assessments
- Maintained close communication across the dermatology and clinical pharmacology teams
The Outcome:
We enrolled 24 of 26 screened participants, achieving a 92% screen-to-enrollment rate.
The complete planned study population was recruited within approximately four months.
Our integrated dermatology and clinical pharmacology model also supported the delivery of intensive systemic and local pharmacokinetic assessments across the sequential dose-escalation cohorts.