Clinical trials give people living with medical conditions today the opportunity to make an enduring contribution to medical research and a chance to help future generations who are affected by these disorders.
These essential studies are designed to evaluate the safety and effectiveness of possible new drugs, medical devices, and medical procedures. The U.S. Food and Drug Administration (FDA) and other regulatory agencies set strict rules for all clinical studies to protect the safety of people who choose to participate.
The BioMendics’ TAMES trial is a Phase I/IIa trial to study the safety and explore the potential efficacy of a new drug to treat epidermolysis bullosa. The drug being evaluated is formulated as a gel that is applied directly to the skin. During the trial, patients will receive both the active drug and the placebo gel, that does not contain any active drug. Patient participation requires 3 on-site visits to the Stanford dermatology clinic, with weekly (maximum of 10 weeks) virtual-only visits with the doctor and research study team. Reasonable costs for travel and accommodations will be covered and participants will be compensated for their time.
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. Participants will undergo biopsy and suction blister procedures at the start and end of the study. These procedures provide vital information about what the layers of a patient’s skin look like under the microscope and inform the clinical research team if the new medication is helping or causing unanticipated harm.
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 epidermolysis bullosa simplex (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.