Sahara Pivotal Axillary Hyperhidrosis Study Patient Recruitment

The Challenge

Nearly 5% of the world's population is affected by Hyperhidrosis (excessive sweating). Axillary hyperhidrosis is a disorder characterized by excessive sweating in the underarms beyond what is necessary for the regulation of body temperature. This condition is explained by patients as an uncontrollable, annoying, embarrassing, and isolating problem that can feel like it is ruining their life.Currently, there are very limited non-invasive treatments available for hyperhidrosis. This is why clinical-stage company Candesant Biomedical posed the question, “Is ‘no sweat in 3 minutes or less’ possible?”. They accepted the challenge and developed a new, non-invasive topical patch that’s applied to the underarms in a physician's office and only stays on for less than 3 minutes. This non-Invasive treatment focuses on axillary hyperhidrosis (excessive underarm sweating) for adults of all ages. With our experience with hyperhidrosis trials, Clinically Media was hired to develop a comprehensive Central Campaign to fill the Sahara research study efficiently with high-quality adult patients.

Additional Challenges Faced

• COVID-19 (site shutdowns, public’s fear of leaving home)
• High screen-fail rate
• Patients must not have treatment with botulinum toxin (Botox) for excessive sweating or hyperhidrosis within 1 year

Study Stats

• 13 research sites
• 120 patients enrolled total
• 2,137 pre-qualified referrals from Clinically Media
• Enrolled ahead of 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

• 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

  Google search ads, local advertising, physician outreach

COMPRESSED TIMELINE

Clinically Media provided pre-screening support for sites so they did not feel any strain in getting the trial filled. This allowed Clinically Media to optimize the number of referrals coming in, sending only the most qualified subjects to the sites and in turn running an efficient and fast campaign.The Sahara study was put on FDA hold after the first month of enrollment. Once reopened in March, Clinically Media was able to enroll the study in about 5 months, approximately 1 month ahead of the expected timeline of 6 months (March 2021 - August 2021). On July 6th, enrollment closed.

CENTRAL CAMPAIGN Results

• 2,137Total prequalified referrals
• 255Total screened referrals
• 110Total randomized patients
• 43%Randomization rate

Clinically Media’s efficiency and attention to detail contributed to the enrollment success of the Sahara axillary hyperhidrosis study.Erin, Senior Director, Clinical, Candesant Biomedical