The BioMendics’ TAMES-02 trial is studying is Actively Recruiting Patients. BioMendics is investigating a topical gel called TolaSure to see if it can help with intermediate and severe EB Simplex blistering. Participants may receive TolaSure Gel or a Placebo Gel (without the active ingredient) during the first part of the study which consists of daily application of treatment for 2months. During the second part of the study, all participants will receive TolaSure gel and treat their blistering skin daily for an additional 2 months. A follow-up visit will take place 2 more months after treatment for a total of a 6-month time commitment. 

Throughout the study, the doctor will monitor each participant through physical exams, measuring vital signs like temperature and pulse, and collecting blood and urine samples. These procedures are important for participant safety. Additionally, patients will image their treated area throughout the study and provide answers to pain, itch, and quality of life questionnaires.

BECOME A PART OF THIS TRANSFORMATIVE JOURNEY:
• Ages 4 and up, males and females
• Diagnosed with intermediate or severe EB Simplex
• Contact us even if you're in another clinical trial or unsure if you qualify
• Note: Genetic testing will be provided if necessary

YOUR PARTICIPATION MATTERS:
• 6-month study (4-month daily treatment application + 2-month follow-up)
• Only 3 on-site visits required
• Bi-weekly remote check-ins for your convenience
• Imaging treatment sites at least weekly
• Option to treat your feet
• Filling out pain and itch questionnaires weekly

WE VALUE YOUR COMMITMENT:
• Reasonable cost for travel, accommodations, and meal expenses will be covered
• Compensation provided for your time during on-site visits

YOUR COMFORT, OUR PRIORITY

The compassionate research teams at Stanford University Dermatology and Northwestern University Dermatology are committed to your well-being throughout the trial. Please
contact one of the sites below for more information, add TAMES-02 in the subject line: Stanford Dermatology: Dr. Joyce Teng (Investigator) & Thomas Buschbacher, tbusch@stanford.edu
For questions about participant’s rights, contact 1-866-680-2906.
Northwestern University: Dr. Amy Paller (Investigator) & Dr. Lydia Rabbaa Khabbaz, lydia.rabbaakhabbaz@northwestern.edu
For questions about participant’s rights, contact 312-503-7110.

For questions about BioMendics or more information about TolaSure: Karen McGuire, kmcguire@biomendics.com

Details about the TAMES-02 Phase 2 Clinical Study can also be found on clinicaltrials.gov

Reasons to Participate in a clinical trial: When you participate in a clinical trial, you play a vital role in medical research and help to advance treatment for yourself or your child and others with EBS. You also receive expert medical care and may be monitored more closely than if you were not in the trial. Many patients have reported that being in a trial made them feel like they were playing a more active role in their own care. Your participation may benefit other patients with EBS or similar conditions in the future.

• Clinical research helps us better understand EB and develop more effective treatments.
• Patient voices shape clinical trial design and endpoints
• Every participant contributes valuable information that can help current and future patients.
• Trials are voluntary, confidential, and carefully monitored for safety.
• No research moves forward without you—your experience shapes the future of care.

Click here to access our social media platforms and sign up to receive emails about an upcoming Epidermolysis Bullosa Simplex Focus Group and TAMES-02 Clinical Trial updates.

Learn more at clinicaltrials.gov and contact the Stanford or Northwestern study site directly for information about the trial.