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 2 months. 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.
Reasonable cost for travel, accommodations, and meal expenses will be covered. Compensation provided for your time during on-site visits.
• 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
Please contact one of the sites below for more information, add TAMES-02 in the subject line:
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Stanford Dermatology (California): Dr. Joyce Teng (Investigator) & Thomas Buschbacher
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Email: tbusch@stanford.edu
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For questions about participant’s rights, contact 1-866-680-2906
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Northwestern University (Illinois): Dr. Amy Paller (Investigator) & Dr. Lydia Rabbaa Khabbaz
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For questions about participant’s rights, contact 312-503-7110.
For questions about BioMendics or more information about TolaSure: Karen McGuire, kmcguire@biomendics.com
Additional details about the TAMES-02 Phase 2 Clinical Study can also be found on clinicaltrials.gov.
