CASE STUDY

Sahara Pivotal Axillary Hyperhidrosis Study Patient Recruitment

Summary

Clinically Media enrolled a Pivotal axillary hyperhidrosis study ahead of schedule. Clinically Media is a group of patient recruitment and retention professionals devoted to empowering individuals to participate in clinical research.

The Details

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

  • 2,137

    Total prequalified referrals

  • 255

    Total screened referrals

  • 110

    Total 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

Other Services Clinically Media Offers

Coordinator Training Materials

Including mobile apps, video, print manuals, tri-folds

Patient Training Materials

Including diaries, trackers, appointment reminders, videos, tri-folds, mobile apps, and more

Branding and Marketing

Including brand packages, logo design, social media, PR, IR

Patient Recruitment

Including digital, social media, grassroots, and traditional advertising methods

what our Partners say about us

Clinically Media has been a total success with our practice! The one-on-one professionalism and honest dedication to growing our population has been a resounding success. We look forward to our continuing relationship, thank you!

Study Coordinator

Windsor Dermatology/Psoriasis Treatment Center of Central New Jersey

Clinically Media exceeded our expectations in their recruitment support for Brickell’s two Phase 3 trials. 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

Brickell Biotech

A true partner from the very beginning -- Clinically Media is a go to team for establishing corporate branding and commercialization planning.  Whether our needs be complete website redesign, social media strategy or efficient market research execution, Clinically Media delivers on time, on budget, with quality work and creative recommendations.  I’d highly recommend this team as an extension of your own.

Commercial Marketing

Candesant

Clinically Media delivered outstanding, high quality creative, visual and graphic web-based solutions within our agreed timelines. I enjoyed collaborating with Victoria and her team, and will definitely consider using their services for future clinical studies. I strongly recommend Clinically Media to other companies.

L. A. Romel

Principal at Lawrence Romel Consulting

Clinically Media’s efficiency and attention to detail contributed to the enrollment success of the Sahara axillary hyperhidrosis study.

Erin Tims, Senior Clinical Director

Candesant Biomedical

Clinically Media did very well and are easy to work with. Will work with them again in the future for sure. And their portal is easy to navigate. Keep doing what you're doing!

James, Study Coordinator

Windsor Dermatology/Eczema and Psoriasis Treatment Centers of NJ

The Clinically Media team is efficient and flexible. They brought new, customized solutions to our recruitment campaign for melasma patients, and they surpassed our goal number of referrals. We enjoyed working with them and hope to work together again in the future.

Dr. Dhawan

Center for Dermatology

We love working with the Clinically Media team. They provide professional, informed marketing advice and analytics, and they always create on-brand and engaging images and captions for Brickell’s social channels.

Chief Marketing Officer

Brickell Biotech

I can't say enough about the quality of work, responsiveness, and flexibility that Clinically Media brought to the project. I hope to have another project that needs Clinically Media's services.

Clinical Operations

Brickell Biotect

Communication was excellent! Worked well with changing a few things to bring in more referrals.

Clinical Research

Hamzavi Dermatology

We are so happy to have partnered with Clinically Media. Working in a small start up environment, we lacked not only resources but expertise. The ideas that CM brought to the table were innovative and fresh, and we saw our boost in enrollment immediately. Victoria and Brenda were not only flexible, but problem solvers -we are grateful to have worked with such a wonderful company.

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