CASE STUDY

Brickell Biotech Phase III Primary Axillary Hyperhidrosis Study

Summary

Clinically Media enrolled two parallel Phase 3 primary axillary hyperhidrosis studies on schedule. Clinically Media is a group of patient recruitment and retention professionals devoted to empowering individuals to participate in clinical research.

Services included: advocacy group coordination, hyperhidrosis, local advertising, paid advertising, patient recruitment, physician outreach, pivotal study, referral management, referral tracking, site management, social media, study branding

The Details

The Challenge

For the 365 million individuals in the world suffering from hyperhidrosis (excessive sweating), the condition has resulted in occupational, emotional, psychological, social, and physical impairment. In addition, hyperhidrosis is undertreated and underrecognized as a serious disorder negatively impacting the quality of life for both adults and adolescents. According to the American Academy of Dermatology, half of people with hyperhidrosis delay treatment for 10 years or more.

With limited treatments available for hyperhidrosis patients, clinical-stage company Brickell Biotech has been developing a new potential non-invasive treatment focused on axillary hyperhidrosis (excessive underarm sweating). Clinically Media was retained to develop a comprehensive Central Campaign to recruit and enroll two parallel US-based Phase III trials efficiently with qualified adult and pediatric patients.

Additional Challenges Faced

COVID-19 (site shutdowns, public’s fear of leaving home)
High screen-fail rate

Study Stats

81 Research Sites
700 patients enrolled total
50% patients enrolled via Clinically Media
Enrollment was completed on schedule

Clinically Media's Solution

STUDY BRANDING
Data-backed umbrella study branding used across all materials, including both recruitment and patient training/retention materials
SOCIAL MEDIA
Trackable digital campaign with an emphasis on highly targeted social media advertising
REFERRAL MANAGEMENT
Intensive prescreening efforts, including an online form and phone screening, and managing a third-party support
REFERRAL TRACKING
In-depth internal tracking to track referrals all the way through enrollment and study completion
SITE MANAGEMENT
Consistent, close communication and follow up with research sites allowed us to provide an individualized recruitment strategy for each site
ADDITIONAL SERVICES
Collaboration with advocacy groups like the International Hyperhidrosis Society, Google search ads, local advertising, physician outreach

Reached Target

Through advanced IT support and customized solutions, Clinically Media was able to develop a cohesive brand, streamline lead generation, and lessen the burden placed on research sites. As a result, Clinically Media successfully enrolled the study in the anticipated 7-month enrollment period.

Overall Results

~12,600
Total prequalified referrals
~245
Total prequalified pediatric referrals

CENTRAL CAMPAIGN Results

985
Total screened referrals
339
Total randomized patients
34.4%
Randomization rate

They were efficient and nimble in providing both an umbrella recruitment strategy and customized support directly to sites to ensure our aggressive enrollment goal was met.

Clinical Operations Project Manager

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